Frequently Asked Questions

Our FAQ page covers the main questions facing our members. Section headers are hyperlinked to the relevant sections on MAP where you can find more detail on the topic of interest (accessible to members for that region only).

Have a burning market access related question of your own? Ask MAP

FAQ Sections

MAP

What is MAP, why should I join MAP Online and how to do I make the most of my membership

MAP and you

What is MAP BioPharma?
MAP BioPharma offers consultancy services that help BioPharma and MedTech clients achieve optimal market access in the UK and Ireland. This is achieved through a combination of a web based membership service which aims to act as a ‘virtual’ expert to hold your hand as you navigate the processes; and also through one to one strategic advice, support for product profiling, pricing and dossier development and to support lobbying activity for when a plan B is needed.

For more information on MAP, please see what we provide.

Am I eligible for membership?
You will usually qualify for membership if you have responsibility for regional or national or international market access, pricing and or government affairs in either the private or public sector, we provide market access professionals with cost effective solutions and tools to support them in their role.
Someone in my company is a member. Does that make me a member?
No, memberships are given to individuals and are not to be shared with colleagues, so it would not make you or your company a member. If multiple people in the same organisation wish to become members, then discounted rates are available for additional people.
How can I see all the latest updates on MAP?
Any major change to the market access process are captured on MAP and reflected in the “Trending this week” boxes under the navigation menu, specific to the changes made in each particular country section while the “Trending this week” on the homepage covers the latest additions across MAP as a whole.

MAP also cover all the latest market access news and consultations, updated on a daily basis.

We also send out a monthly newsletter, detailing all the market access updates, news stories and improvements made to the website. Contact enquiries@mapbiopharma.com for more information.

Saving you both time and money

A few colleagues are planning to join MAP Online. Are there incentives for more than one person becoming a member?
Yes, we can offer a reduction when more than one individual from the same organisation applies for a membership to MAP. We recommend that you contact us via enquiries@mapbiopharma.com to let us know your requirements and we will respond within 2 working days.
Why should I join MAP Online for more than one year?
If you choose to join for multiple years you will be eligible for a reduction to the membership fee. You will also be safe in the knowledge that you will be receiving continuous support without needing to renew your membership.

We are also continuously improving and updating our website which can help you keep up to date with the latest market access information.

As a growing company I have to justify my costs. How can MAP save me money?
Subscription can deliver tangible savings for you and your business over the course of the year in a number of ways. For example, having access to simple flowcharts and timelines for UK and Ireland pricing and HTA processes allows you to gain focussed consulting support only where really necessary; savings could swiftly outweigh the annual cost of membership as well as reducing the time required to understand market access processes, evaluate options and make decisions.
I am busy in my role, would I have time to utilise the benefits?
We appreciate that your time is precious and have specifically designed our services to be efficient for you in an easy to follow format which is applied consistently throughout the website. This will particularly save time when you have to navigate processes in one part of the UK when you are already familiar with another, and to make comparisons between them to help you plan workload and resources, for example an SMC and NICE submission.

Meeting your individual needs

What is Market Access?
Market Access means different things to different people. MAPs definition is that Market Access is a label for the main activities required for a doctor to gain reimbursement for and prescribe the right medicine to the right patient at the right time.

Please see Market Access Overview in Europe for different perspectives of Market Access.

I have worked in market access for a number of years. Would a membership still be of benefit to me?
Subscription is there to supplement your existing knowledge at whatever stage of your career you are at when you choose to join MAP Online. We will keep you up-to-date on the latest market access legislation and current business challenges and solutions. Subscription can support you in your day-to-day business activities, saving you both time and money, and providing concise answers to your market access, pricing and government affairs questions through ‘ask MAP’.
How can I find out more information about a membership?
If you have any further enquiries or questions regarding a membership, please contact us via enquiries@mapbiopharma.com
How do I give feedback, request a change or make a complaint?
We do value our member’s concerns and opinions and we are sorry if we did not meet your expectations. Should you wish to provide feedback, request a change to the website, or make a complaint, you can get in touch:

By email: enquiries@mapbiopharma.com
By telephone: +44 (0) 1480 832360
We will endeavour to resolve complaints within 2 working days.

Europe

MAP Europe is provided to all of our members as a complementary supplement when you join MAP Online to any MAP country. It covers aspects of market access that are applicable across the EU however if your question is not here, please see the individual country sections or ask us.

Parallel Trade

Is it possible to monitor parallel trade?
Parallel imports are perfectly legal and are a direct consequence of differences in prices between EU Member States and of the development of the Internal Market which guarantees the free movement of goods. However, there are certain pricing strategies that can be implemented by the company or government to monitor parallel trade.

See our international reference pricing section for more information on these strategies, complete with a case study.

Orphan Products

What is the orphan drug designation criteria?
To qualify for orphan designation, a medicine must meet a number of criteria (Ref: EMA website):

  • it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
  • the prevalence of the condition in the EU must not be more than 5 in 10,000 (or 1 in 50,000 for ultra orphan products) or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;
  • no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition
How does the reimbursement process differ for orphan products?
Different countries have different provisions in place for orphan and / or ultra-orphan products. Some countries such as Germany have special reimbursement criteria for orphan drugs such as accepting less robust evidence, or allowing studies to use surrogate endpoints rather than only ‘hard’ endpoints.

Countries that do not have orphan specific HTAs may have certain policies that are applicable to orphan products. Italy for example has a fast-track mechanism which can allow orphan medicines to enter pricing / reimbursement negotiations before market authorisation.

Is there a cost-effectiveness threshold for an ultra-orphan product?
There is no pre-defined cost-effectiveness threshold for ultra orphan treatments evaluated under the HTA process but, for example in England, a cost of £300,000 per QALY is believed to be the maximum acceptable ICER. This is is substantially more than NICE’s current threshold of £30,000 which covers all orphan and non-orphan treatments.

UK

MAP UK is a member only section that covers market access content applicable to the UK as a whole as well as the differences between each of the devolved nation. Non-members can get an overview of the structure and contents by clicking on the table of contents.

Brexit

What are implications of Brexit on the Life Sciences industry?
No immediate change. The Government is expected to initiate Article 50 of the Treaty of Lisbon in the autumn to begin the negotiations as a departing country.

For the following two years there will be little change in European business dealings. The UK will remain part of the EU for this period and subject to EU rules. The main change is that the UK would no longer be able to participate in the discussion of the European Council of Ministers or in the decisions concerning it.

Most businesses will therefore not take immediate decisions but will wait to see how negotiations between the UK and the other EU members develop.

See MAP’s full coverage on Brexit here.

How long will the negotiations take?
Negotiations for Greenland to leave the EU took three years, and the main issue was fish. For the UK the issues are much more complex and a timescale of 5-7 years seems a reasonable estimate.

MAP have developed a Brexit section answering the main questions and concerns facing life science companies following the Referendum.

What will be the UK’s relationship with the European Medicines Agency (EMA)?
The EMA internal organisational and licensing arrangements are restricted to EU and EEA members. However, it would be sensible for the UK to negotiate a Mutual Recognition Agreement with the EMA so that what is agreed by the one will be accepted by the other. Such agreements already exist between the EMA and Switzerland, Canada and Australia.

MAP have developed a Brexit section answering the main questions and concerns facing life science companies following the Referendum.

Pricing

Is it possible to increase the NHS list price due to the drop in the pound following Brexit?
Unfortunately, the DH does not consider exchange rates in their pricing negotiations and therefore the drop in the pound can not be used to justify a price increase.

You can find more details on our “Renegotiating a price” on MAP.

How are prices for generic products set?
‘The selling price of a licensed generic product has freedom of pricing as set out in Scheme M, which is a voluntary agreement between DH and the British Generics Manufacturers Association (link to Scheme M). If the company is new to generics and wishes to join Scheme M, please have them complete and return the Annex A – Scheme M form.

Where a NHS prescription is dispensed by a NHS dispensing contractor, the reimbursement price of the dispensed product will be as outlined by Clause 8, Part II of the Drug Tariff. The Drug Tariff can be accessed here.‘

How do we fend off price comparisons of a new innovative technology to a generic product?
The EUCOPE position paper has been adopted by MAP to answer this question. Our Managing Director Christian is also a board member of EUCOPE and contributed to the considerations that the paper addresses. Please let us know if you would like more information to tackle specific scenarios, which we could work up on MAP.
What is the difference between NHS medicines for home, NHS medicines export and other products?
NHS medicines home:
Licensed, branded medicines covered by the PPRS are labeled as NHS Medicines. If these medicines are sold to the NHS they are categorised as NHS medicines home.NHS medicines exports:
NHS medicines (see above) that are exported outside of the UK.Other products:
Sales / costs related to products not covered by the PPRS (products other than branded medicines with a UK product license), for example medical devices or generics.

For more questions regarding pricing and the PPRS, please see our Pricing FAQ.

Early Access

Will the accelerated access review (AAR) affect the EAMS funding arrangements?
the AAR is expected to include provision for some changes to the PIM/EAMS process including, we hope, paid early access to medicine while companies collect data. If this happens, then we anticipate a surge in PIM/EAMS submissions.

Therefore, there is a tradeoff between early application FOC (with potentially a higher likelihood of positive outcome) or later application with possible paid access.

Patient Access Schemes

How do patient access schemes differ between the four UK nations?
See our PAS section for a side by side overview of each of the PAS systems across the four UK devolved nations.
If a PAS gains a positive recommendation from PASLU in England, is it applicable across the 4 devolved nations in the UK?
The Pharmaceutical Price Regulation Scheme 2014 (PPRS) is a UK-wide agreement, covering England, Wales, Scotland and Northern Ireland. The PAS provisions in the PPRS refer explicitly to England and Wales, because of the link between PAS proposals and NICE appraisals.

However, while NICE guidance does not automatically apply in Scotland and Northern Ireland, the NHS in Northern Ireland does routinely follow NICE recommendations. In view of this, the membership of PASLU’s Expert Panel includes a representative from the health service in Northern Ireland and the expectation is that PAS should normally be offered in Northern Ireland on the same terms as in other parts of the UK. If you have any further queries about the approach to PAS in Northern Ireland, we would suggest following up directly with colleagues in DHSSPS (SGU-NICEGuidance@DHSSPSNI.gov.uk).

For Scotland, the Patient Access Scheme Assessment Group (PASAG) reviews and advises NHS Scotland on the feasibility of proposed schemes for implementation. PAS agreed by DH and NICE in England / Wales do not automatically apply to Scotland, but it is the expectation that schemes should be offered on the same terms. You could contact PASAG Secretariat (NSS.NP-PASAG@nhs.net) in the first instance.

What if we offer a PAS but then get negative HTA guidance, can we still offer the PAS to hospitals and primary care services?
Ask one of the boards directly if they’re still permitted to do individual deals with companies via an Individual Funding Request (IFR, IFTR, IPTR) rather than any discounts being arranged purely through NHS Scotland centrally.

Another option at a later stage is to approach NHS Scotland Procurement and / or PASAG and re-offer the PAS through them so that they feel reassured. All that they would need in any case is a letter from you to say that you’ve changed your mind and will make the PAS available to boards, and that the terms of the PAS apply in any IFR situation.

As the PACE process is a bit new and so analogues are in short supply, we suggest talking to us when you are ready to face this situation at the specific point in time so that we can add current context from HTAs that we are managing.

How many Scottish HTA submissions have included a complex PAS?
Please see our complex PAS section complete with a table summarising the complex PAS submissions, including the SMC’s ICER view, the SMC’s decision and date published.

Vaccines

What is the market access route for an influenza product (IV)?
  1. The JCVI (joint committee on vaccinations and immunisations) recommends the Department of Health (DH) on vaccination and pricing – Dr Mary Ramsay is head of immunisation at PHE and leads the JCVI secretariat
  2. DH negotiates price – Carolyn Heaney (Deputy Director Immunisation) is a key figure in this process and is different from the DH pricing process for medicines
  3. PHE holds the national immunisation team, which can be confusing in context of JCVI, DH and NHS England responsibilities
  4. Public health steering group at NHS England makes recommendations on implementation of ministerial decisions to introduce or change immunisation and reports to the senior oversight group. John Holden (Director of Policy, Partnerships and Innovation should be engaged)
How would we go about getting a price for influenza vaccination (IV) – would it be classed a medical device?
A license is the first step, like a medicine. The JCVI provides cost effectiveness models, which are then used to support national tenders via the Department of Health (DH) but they only meet three times a year. The DH gives advice to NHS England and PHE and is crucially in the position of negotiating price and any changes to existing provision (assuming you’re going up as a head to head competitor to existing flu vaccines).
Who are the main stakeholders in the Department of Health (DH) , Public Health England and NHS England for influenza vaccinations?
We are unable list individual contact details without their express permission. Please contact MAP if you would like to get in touch with specific stakeholders in the DH or PHE. We can also provide a list of the JCVI, NHS England and interested Ministers.
How does the Department of Health (DH) handle the procurement of influenza products?
This has partly been described above. The IV product is a dtN2 strain, and the WHO recommendation includes changing the dtN2 component to include a vaccine strain to better match the drifted dtN2 strain seen in the Northern Hemisphere 2014/15 flu season in the Flu Winter Plan 2015/16.

England

NICE

How do NICE assess medicines for an end of life eligibility?
You must satisfy certain a criteria in order to be acknowledged as an end of life drug including:

  • the indication normally leads to death within 2 years
  • patients should gain more than 3 months’ extra life

*Note that the population limitations (of up to 7,000 patients) no longer apply.

Treatments that meet the NICE end of life criteria may be considered cost-effective up to an ICER of £50,000.

If a company get an “only in research” recommendation from NICE, what impact would this have commercially for a product?
NICE do not give funding directions when they provide only in research recommendations. Therefore, such guidance is likely to result in NIHR sponsored studies, where the technology may or may not be paid for.

Positive MAP Insights
NHS England would be very likely (based on recent experience) to interpret such guidance as being equivalent to not routinely commissioned. That said, if such a company participates in research as suggested by NICE, then they would reasonably expect to receive positive guidance as long as the research study were positive.

The drug or treatment is recommended for use only in the context of a research study, for example a clinical trial. Often, particularly in the case of promising new technologies, sufficient clinical evidence has not been collected at the time of the appraisal and so the Appraisal Committee is unable to recommend the technology for use in the NHS until further evidence on its effectiveness is available for re-appraisal.

For more information, see our NICE technology appraisals page.

What are NICE Quality Standards?
NICE Quality Standards are a concise set of prioritised statements designed to drive measurable quality improvements within a particular area of health or care.

For more information please see the NHS Tariff Solution page in MAP UK

Is not submitting to NICE an option or are there consequences?
As illustrated on the England pages on MAP, there is a serious risk of unpredictability in gaining reimbursement through commissioning arrangements if a request for a NICE submission is refused.

However there are alternate routes to market if you choose not to submit to NICE:. They are:

  1. Commissioning policies
  2. Clinical Commissioning Groups
  3. Individual funding requests (IFRs)
  4. Commissioning through evaluation

It is possible to gain reimbursement on the NHS through one of these routes in addition to “the report from accelerated medicines review (Innovative Medicines and MedTech Review) which may provide a steer for how [NHS England] review and reimburse medicines in the future”. However, “the NHS has an allocated fixed budget which [NHS England] must remain within. Therefore, [their] role is to prioritise those treatments that are ‘new’ to the NHS”. Furthermore, if NICE do review the drug in future, then their “[recommendation] will supersede any recommendations [NHS England] make within [their] own clinical policy”, as stated by James Palmer, Clinical Director Specialised Services, in his letter from NHS England to Eucope.

What are the main factors taken into account by NICE when reviewing a technology?
The process by which it is initially determined whether NICE should look at reviewing a technology or not is based on 5 things:

  1. Is the technology likely to have a significant health benefit, taken across the NHS as a whole, if given to all patients for whom it is indicated?
  2. Is the technology likely to have a significant impact on other health-related government policies (for example, reduction in health inequalities)?
  3. Is the technology likely to have a significant impact on NHS resources (financial or other) if given to all patients for whom it is indicated?
  4. Is there significant inappropriate variation in the use of the technology across the country?
  5. Is the Institute likely to be able to add value by issuing national guidance? For example, in the absence of such guidance is there likely to be significant controversy over the interpretation or significance of the available evidence on clinical and cost effectiveness?

Clinical Commissioning Groups (CCGs) Funding

Concerning the point “funding in England is predominantly provided regionally by CCGs …” – does it mean in practice, that a company has to negotiate with hundreds of CCGs?
In practice, it is generally the case that negotiation with groups of CCGs is acceptable, but these are still in the high numbers, although admittedly not hundreds. We have recently gained a view from NHS England on the evolving situation with CCGs. This includes the inclusion of what is called co-commissioning, whereby CCGs now begin to actually buy services directly including primary care services. I attach this review document, which I hope is both helpful in your general understanding of the evolution of the English NHS and more specifically to understand how this will impact uptake decisions in the future. Ultimately, it is certainly the case that not having a NICE guidance will make uptake very much more difficult.
How can a company directly apply to NICE to review and how does the process work?
NICE do not appraise all new medicines entering England’s market. New drugs therefore undergo a topic selection process where they are filtered and prioritised by NICE for a health technology assessment (HTA). There are ways in which a company may increase its chances in order to be review by NICE which can be found on the MAP NICE Topic selection page, specifically under ‘How to Increase the Likelihood of a NICE Review‘.

BlueTeq

What is BlueTeq?
BlueTeq is a web-based clinical decision support system. It is an important tool used by NHSE to monitor and control expenditure of high cost drugs and devices used in specialised services. It is used to support the implementation of the CDF and high cost drugs as well as having a specific tool for managing Individual Funding Requests (IFRs).

Visit MAP’s BlueTeq section for more information, complete with introductory slide decks and a BlueTeq specific FAQ

NHS

What is NHS England responsible for commissioning?
  • Statutory responsibility for commissioning primary care services
  • Clinical Commissioning Groups (CCGs) have a statutory duty to support NHSE in the quality of primary medical services
  • Community pharmacies, dispensing doctors and appliance contractors
  • NHS dental services and sight tests
  • Highly specialised/specialised services and high security psychiatric services
  • Health services for those detained in prison and other custodial settings
  • Some services for members of the armed forces and their families, where registered with Defence Medical Services
  • NHSE will commission some services on behalf of Secretary of State
  • Public health services for children aged 0-5, including health visiting and family nurse partnerships
  • Immunisation and screening programme
  • Public health services for those in prison or custody
  • Sexual assault referral services
  • Child Health Information Systems (CHIS)

‘Primary Care’ is clearly distinct from secondary care, both in clinical and financial terms. Primary Care – as defined under the NHS Mandate and as commissioned currently by NHSE consists of:

  • GP services
  • Dental Services
  • Ophthalmology services
  • Community Pharmacy services
  • Clinical revalidation and contract management

Visit MAP’s NHS England FAQ section to see the full list of questions raised by our members with answers verified by NHS England officials

How do we update GP IT systems with newly approved prices?
See the MAP pricing section which includes a how to guide on who to inform (NHS Business Services Authority – who then inform each IT system for you), but also need to inform BNF, and MIMS if you want the product to be listed there.

The NHSBSA also confirmed that the new system does automatically update the clinical systems. There are two email addresses to start registration for eMC In-demand:
– they will email you back with a form to be completed
– they will call you back and start the process over the phone

Scotland

New Medicines Fund (NMF)

What is the NMF?
The New Medicines Fund (NMF) in Scotland was launched by the Scottish Government to cover the costs for orphan medicinal products.

The NMF has been successful in the commissioning of highly specialised services and products for patients in Scotland with complex or rare/orphan conditions and its budget doubled to £80 million for 2015/16.

The NMF is now one of the key routes to reimbursement for high cost drugs and is funded by the PPRS payments from the UK Department of Health to NHS Scotland.

What is the NMF process?
The exact mechanism to access the NMF is not published, and there is no official application form for companies or Health Boards (HBs) which tend to pay for medicines from their own budget under the IPTR (Individual Patient Treatment Request) or PACS (Peer Assessed Clinical System) process OR they ask NHS Scotland for support from the NMF at the end of the year to reimburse their spend, which is either reimbursed or not depending on what is available in the fund.

One exception appears to be the Greater Glasgow HB, who report that Kalydeco is actually reimbursed to them by the Scottish Government directly.

Positive MAP Insights
Based on current MAP client experience, the appropriate routes to gain NMF access are to:

    • Have local clinical experts apply for IPTR funding to their HB
    • Engage with NHS HIS directly to ask for consideration of funding on a national level (not expected to be an alternative or any more successful than individual clinicians approaching their HBs directly, but may be considered in parallel)

Peer Approved Clinical Systems (PACS)

How does the PACS system differ to the current IPTR?
The Peer Approved Clinical System (PACS) focuses on patient outcomes and is aimed at giving clinicians more of a say in which drugs that are yet to be approved or are not normally recommended by the SMC can be accessed by patients whereas Individual Patient Treatment Requests (IPTRs) are requested by clinicians but the final decision is made by the IPTR panel.

See our IPTR section within MAP UK for more information such who makes up the IPTR panels.

Wales

Orphan Products

What is the orphan policy in Wales? i.e. how are orphans treated by AWMSG?
Please see the MAP Welsh orphan and ultra-orphan section for a more in-depth overview of the Welsh orphan policy.

The Welsh orphan policy largely mirrors what the Scottish system brought in, whereby patients’ voices are a part of the assessment, and multiple criteria are considered in the value assessment including what they call orphan modifiers such as (amongst other criteria) the degree of severity of the disease in terms of survival and quality of life impact, whether a medicine can reverse or cure a condition rather than stabilise the condition and also added value that may not be adequately captured in the QALY calculation. The full update from the Welsh group can be accessed here.

Would the AWMSG review an orphan disease product if NICE has already reviewed or plan to review the orphan product?
AWMSG will not normally review a product if NICE is scheduled to publish final guidance within 12 months of marketing authorisation. However, they occasionally do and in such cases the advice is interim until NICE publish their own. You should always aim to get form A into AWMSG around the time of CHMP or MA though, as you can at least get into a discussion with them, without them thinking that you’re trying to avoid the process

Northern Ireland

Reimbursement

How are new medicines assessed in Northern Ireland in NICE or SMC have not reviewed the product?
The DHSSPS in Northern Ireland conducts a review of products on a case by case basis but does not technically carry out a HTA even in the absence of NICE or SMC guidance or advice respectively.

Please see our HTA Guidance for Northern Ireland in MAP UK for more information.

Republic of Ireland

The processes for pricing and reimbursement differ to that in the UK. MAP Ireland helps distinguish those differences, guiding you through the market access process in Ireland.

Reimbursement

What products are excluded from the term “medicine”?
The definition of medicines in the IPHA Framework agreement is as follows:

“Medicines” means any patent-protected Medicinal Products and any off-patent Medicinal Products (and which have not been declared interchangeable by the HPRA pursuant to the 2013 Act), excluding blood products, vaccines and non-reimbursable non-prescription products without prejudice to clause 13.2, and in respect of which a Marketing Authorisation has been issued (and “Medicine’ shall mean any one of them).

What are the different drug reimbursement schemes used in Ireland?
The Primary Care Reimbursement Service (PCRS), on behalf of the HSE, pays for the free or reduced services provided by healthcare professionals in Ireland to provide a better healthcare system for all citizens. The main schemes are:

  • General Medical Service (GMS) Scheme –patients are issued a Medical Card which entitles them to a range of Health Services free of charge. A €2.00 charge applies to all prescription medicines, up to a maximum charge of €20.00 per family per month, plus the pharmacist dispensing fee
  • Drugs Payment Scheme (DPS) – individuals and families do not have to pay above a monthly threshold of €144 (HSE)
  • Long-Term Illness Scheme (LTIS) – people suffering certain chronic conditions (see the HSE LTIS page for a list of all the diseases included) are entitled to full drug reimbursement free of charge, irrespective of income
  • High Tech Drugs Scheme (HTDS) – facilitates the supply of high-cost medicines, which are normally only prescribed or initiated in hospitals, through community pharmacies
  • Hospital only – commissioned by hospitals and paid for from their overall budget
Where do all the forms sit for price and HTA submissions in Ireland?
The HTA submission forms can be found on the websites:

Please see the MAP Ireland flowchart which has links to all of the forms in the pdf links along with an easy to follow overview of the entire reimbursement process for new medicines in the Republic of Ireland, stating when and were to submit forms during the HTA process.

Rapid Review

Which products are recommended for a full PEA following a rapid review?
Products are only subjected to formal PEAs if they are likely to have a significant impact to the budget (e.g. high cost products) or when there is uncertainty about the data or evidence used.

Similarly, products where there is a query in relation to value for money will also be selected for formal PEA. See the guidelines below which include guidance on economic evaluation, budget impact analysis, social, ethical and organisational aspects of HTA and recommended reporting formats.

Pricing

How is the price set for a product if the new medicine is not available in any of the basket reference countries?
If a new medicine is not available in any of these states, the Irish price to the wholesaler will be agreed between the manufacturer concerned and the HSE within 180 days of the date of reimbursement application.
Is there a mandatory tax of 5.25% added to pharmaceutical prices?
There is a 5.25% rebate that has to be paid on medicines purchased by the HSE either via its community reimbursement schemes or public hospitals. The rebate percentage will increase to 5.5% in August 2018.

France

The French healthcare system has been ranked as the best in the world out of 191 countries assessed by WHO. France has a good robust methodology for assessing new medicines coming to market with early access available to new innovative medicines as well. See MAP France for more information.

Reimbursement

How are new medicines evaluated against current / existing treatments?
When a products actual benefits (SMR) are sufficient, its improvement of actual benefit (ASMR) is then discussed. It will be used to provide a basis for pricing in comparison with alternatives. This is a comparative assessment with existing products. If it is the first product in its class, the evaluation is done in comparison with products of the same pharmacological class that are already enlisted. There are five levels of ASMR, appreciating some progress compared with available treatments or existing care:

  • major (I)
  • important (II)
  • moderate (III)
  • minor (IV)
  • no improvement (V)

A medicine which does not bring progress (ASMR V) can be registered on the reimbursable list only if it brings an economy in processing costs. It means that the price will be inferior to the average price of its ATC.

What are the 2 lists that cover reimbursement in France?
There is a list for those drugs dispensed by retail pharmacies and one for those dispensed by hospitals. Drugs can appear in one or both of these lists.

For more information about the enlistment process see the reimbursement process in France.

Germany

The pricing and reimbursement process in Germany has changed significantly in recent years. In January 2011 a new system was introduced to determine the reimbursement prices of new active substances entering the German market. This new system, known as the “AMNOG-System” foresees a 2-step procedure which new medicines have to undergo as soon as they enter the German market. See MAP Germany for more information.

AMNOG

What is AMNOG?
AMNOG is an abbreviation for “Arzneimittelmarkt-Neuordnungsgesetz” (Act on the Reform of the Market for Medicinal Products) a law aiming at the reform of the German pharmaceutical market that entered into force in January 2011. Main purpose was the introduction of a mandatory HTA-assessment for new active substances entering the German market from January 2011. Although actually being the title of a law the term AMNOG is commonly used synonymously for the new system this law introduced.

The AMNOG focuses on ensuring that new patented medicinal products are supplied at a fair price to the statutory health insurance funds. This mean that for the first time the patients benefit rather than the pharmaceutical companies who previously held a price monopoly of the German pharmaceutical industry.

Scope
The mandatory benefit assessment applies to all new active substances entering the German market as from January 2011. This refers to nationally approved pharmaceuticals as well as those that have been centrally approved by the EMA. Products with an annual turnover of less than 1 million Euros can be exempt from the assessment on application. Orphan medicinal products are generally subject to the assessment, although special conditions apply for those with an annual turnover of less than 50 million Euros (Sec. 35a subs. 1 clause 10 Social Code Book Volume V, Sozialgesetzbuch Band V – SGB V).

More information on the scope of AMNOG and on orphan products in AMNOG can be found on MAP Germany.

How did AMNOG change the German system?
Before the introduction of the new system the pricing of new pharmaceuticals in the German market was at the discretion of the respective manufacturer/ marketing authorisation holder (MAH). The price determined by the MAH was fully reimbursed in the German statutory and private health insurance system.

With the introduction of AMNOG a manufacturer introducing a new innovative medicinal product to the German market may still freely determine the reimbursement price of the drug in the German statutory health system. However, this freely determined price will only apply for one year. During this year the drug will have to go through the AMNOG procedures to determine a new (reduced) reimbursement price. The procedures basically consist of two steps:

  1. Benefit assessment, conducted by the Federal Joint Committee (“Gemeinsamer Bundesausschuss – GBA”) where the drug is assessed against an established comparator therapy
  2. Negotiations of the manufacturer with the statutory health insurers (“GKV-Spitzenverband – GKV-SV”) where the new reimbursement price is determined on the basis of the preceding assessment

The new price as determined in the negotiations will apply as of the 13th month after the product was first introduced to the German market.

Is the AMNOG preventing innovation?
No, the AMNOG will allow authentic innovations that tangibly improve patient care to increase. Stopping medicines which are launched with a considerable amount of marketing activity but which do not actually deliver from monopolising the market will do this, as it will no longer be worthwhile for the companies.
Can companies opt-out of the AMNOG reimbursement process?
Within four weeks after the GBA’s final resolution the pharmaceutical manufacturer is entitled to opt out of the AMNOG procedures. This is the only option foreseen to leave the procedures. However, there have been cases where manufacturers opted out at a later stage in the procedures or after the end of the negotiations. As a consequence of an opt-out the pharmaceutical will not be reimbursed in the German statutory health system and will have to be withdrawn from the German market.

See the Re-entering the German market after an Opt-out in MAP Germany for more information.

What pharmaceuticals are exempt from the AMNOG process?
The requirement for an exemption is that the expected long-term revenue from sales to outpatients charged to statutory health insurance must not exceed 1 million euros within 12 calendar months. In general, the pharmaceutical company must submit a petition to the GBA in accordance with the GBA rules of procedure, chapter 5, section 15 if it wants a pharmaceutical to be exempted from benefit assessment in accordance with SGB V, section 35a.

Orphan products with an annual turnover of < €50 Million are also not assessed.

How are pharmaceuticals which were marketed in Germany before 2011 assessed by AMNOG?
Pharmaceuticals that have been in the German market before 2011 are not generally in the scope of AMNOG. Manufacturers of these products therefore do not have to hand in dossiers without having been asked. However, until November 2013 the GBA was entitled to call any product in the existing market for assessment as well (so called “Bestandsmarktaufruf”). This could happen at any time and required the submission of a full dossier within 3 months after the GBA’s request.

More information on the scope of the GBA and AMNOG can be found our reimbursement section in MAP Germany

The new German coalition government agreed in Fall 2013 to abolish the assessment of products from the existing market, whereupon GBA suspended all pending assessments. The law enacting this change has been passed by the German parliament in late spring 2014. The law did retrospectively cancel all pending assessment.

Reimbursement

How are comparators chosen for the GBA assessment?
By law, the choice of the appropriate comparator therapy for the assessment is at the discretion of the GBA. The GBA might, for this purpose consult the IQWiG, a semi-public scientific institution involved in the AMNOG process.

In some instances, there may be several comparator therapies that are equally suitable for the assessment of the additional benefit. According to the law, the choice between these therapies is left to the manufacturer. The manufacturer’s choice will only take effect for the actual benefit assessment but not for the subsequent pricing process.

More information on the comparators can be found on MAP Germany.

Pricing

Do the refund rate negotiations constitute negotiations on price?
The list price of the medicine set by the pharmaceutical company on launching it on the market remains unchanged. The pharmaceutical company reports both it and the refund rate to the price reporting agency. From the 13th month after market launch, the refund rate in accordance with section 78 subsection (3a) of the Medicinal Product Act (AMG) is however the relevant sales price of the pharmaceutical company, which then becomes the reference for the manufacturer’s discount, turnover tax and co-payments.
Is there a way of circumventing the price freeze?
At present it seems to be possible to circumvent the price freeze by reintroducing an older API by a different subsidiary of the manufacturer. However, this would only be possible for APIs that have first been introduced before AMNOG (1st January 2011). For all drugs introduced thereafter, AMNOG procedures will apply also to subsequent new indications and dosage forms.

More information on the price freeze can be found on MAP Germany including an real example and the outcomes of such actions.

Spain

MAP Spain covers the decentralised Spanish healthcare system which makes pricing and reimbursement in Spain different to that seen in other MAP countries. Different regions are in control of their healthcare and funding for medicines, leading to slight variations in healthcare provided from region to region.

Reimbursement

If a drug is approved nationally, does that mean that all regional areas must approve the drug?
Not necessarily. While most regions accept the decision made by the regional body AEMPS, each region can conduct its own HTA. The larger CCAAs tend to review new drugs leading to slight differences in the reimbursement and budget impact.
If a drug is rejected at the national level can it still be reimbursed at a regional level?
No, if a drug is not approved at the national level then it can not be reimbursed regionally.

Italy

Similar to Spain, Italy also has a decentralised healthcare system. However, Italy currently uses the Motola’s system, for ranking innovation of new drugs. Reimbursement and base price levels are set nationally with different discounts set in each individual region. See MAP Italy for more information.

Reimbursement

What is the Motola system?
The Motola system is a method used to rank drugs based on their level of innovation. The degree of therapeutic innovation is scored by evaluating the seriousness of the disease, the availability of previous treatments, and the extent of the therapeutic effect. The medicines are finally categorised into one of three degrees of therapeutic innovation (important, moderate or modest).

Pricing

How often to companies have to engage in pricing negotiations with AIFA for a product?
The negotiated ex-factory prices are established for 24 months (unless stated otherwise) and is subject to an implied renewal for an additional period of 24 months unless previously terminated by either party