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Future of Market Access – a Pharma Perspective
1. Future of Market Access – a Pharma Perspective
Anne-Toni Rodgers
(presentation reflects personal opinion and should not be taken as
representing AstraZeneca).
2. Market Access
“ensures that patients have access
to products and services, when
and where they need them and
that in turn the products and
service are fairly priced and
reimbursed”
Anne-Toni Rodgers June 2002
4. So you already know its not getting easier
• Increasing demand
• Financial challenges
/Austerity Measures
• Innovation
• Lack of trust OECD healthcare costs grown 2% faster than GDP
Most developed economies, growth in pharma
spend lags behind healthcare
In developing markets, pharma spend growing
quickly off a low base (outpaces total healthcare
spend)
5. The Future : 4 different types of access markets
Source : McKinsey 2012
6. UK Healthcare Economic Challenge
….. made simples
demand
funding
efficiency savings
Not going to get
much better!
2010 2015
7. What could reduce Health system costs by upto 20% ?
Potential savings (% of total system cost)
100
1-2
0.5-1.5
2-3
1.5-2
0.5-1.5
2-3
3-2
2.5-3 81-87
Baseline Focus on Prioritise Manage Mobilise Optimise care Implement Optimise Reduce non Potential
Prevention spend - LTCs patents settings / best practice Clinical Ops clinical costs reduced
excess manage spend
utilisatoin provider
network
Use the user
Redesign care across care pathways
Manage Providers
SOURCE: “Achieving world class productivity” produced for DH 2009. More cost-effective interventions includes stopping procedures with no clinical benefit,
reducing the least cost effective interventions, and utilisation reviews to enforce guidelines
8.
9. What else?
• New Customers : Health & Wellbeing Boards:
• Co-payments & Personal Health Budgets
• Patient Access Schemes
• Joint Working –Pharma & NHS
• Non-Clinical Prescribing
• National Service Frameworks (NSFs) and local health promotion/ disease
prevention programmes
• Quality Outcomes Framework
• Clinical, eg CHD, stroke and transient ischaemic attack, hypertension, diabetes, chronic kidney
disease, COPD, epilepsy, cancer, dementia, depression, mental health, asthma, hypothyroidism,
smoking, obesity.
• Organisational, eg patient records and information, patient communication, medicine management.
• Patient experience, with indicators such as consultation length, patient surveys, and patient
experience of access.
• Additional services, inc.cervical screening, child health surveillance, maternity services,
contraceptive services.
• 11 new indicators take effect from 2011-12 covering quality and productivity including rewarding
more clinically-effective and cost-effective prescribing
• Traditional NICE + NICE Quality Standards
10. Prescribing & subsequent increase in medicines
spend is part of the plan
• Prescribing in line with NSFs and local disease prevention programmes.
• More patients being diagnosed and treated, especially in areas such as
diabetes, cardiovascular, and respiratory disease.
• The QOF provision of the GMS contract.
• NICE guidance.
• Patient Engagement : ageing and increasingly well informed patient
population
But will it be funded?
12. Rewarding investment in innovation – what’s changed?
Return until patent expiry
£
Patent challenge Appeal /litigation
negative ruling supports patent
Patent Expiry
Clinical & Payer
Acceptance Tenders impact
Steady growth sales
Government price
cut & forced
Slower uptake by discounts Competitor goes of
prescribers /Payers patent price Patent Expiry
referencing reduces
HTA assessment price
reduces price & limits
volume =
Reduction in sales time
13. Key challenges & opportunities:
• NHS capacity to deliver efficiency & change
management at the same time
• NHS reform
• Introduction of value-based pricing
• Drugs budget = visible low hanging fruit
• Health & Wellbeing Boards
• Personal Health Budgets
14. Pharma role in delivering Market Access
Market Access
“ensures that patients have access to
products and services, when and
where they need them and that in turn
the products and service are fairly
priced and reimbursed”
Anne-Toni Rodgers June 2002
15. Pharma role in delivering Market Access
R
R
Ight product
R
ight patient
RR
ight place
ight price
R
ight data
ight customer
RR ight message
ight time
16. Meeting the need of the future NHS……..
…………..requires a step change
17. Products Customers & Patients
• Differentiation relative to • Payers (National, regional, Public, Private)
standard of care instead of • Clinical Decision Leaders & NICE
innovation alone
• Providing patients with information
• Fewer me-toos & fewer
blockbusters
• Monitoring compliance – pills & guidelines
• Outcomes Pricing – • Patient co-pay (own budgets)
relevant to NHS • Non clinical Prescribers
• Different prices/indication • New ways to communicate
Data Trus
t People
• Comparative not absolute • Vision to change across the organisation
benefit vs different discovery to patent expiry and beyond
interventions
• B2B/ KAM model
• Real world, not just clinical
& throughout the life cycle
• Payers as customers (not hurdles)
• National & tailored • New skills & leadership
• Detailed knowledge of care • Strategic solutions & partnerships not just
pills
pathways, interventions &
cost drivers • Transparency is a given
19. Value-based pricing framework proposals
• VBP across the UK for new branded medicines in 2014.
• Manufacturers propose NHS price for new product, (basis of value
assessment =, patient benefits, unmet need, therapeutic innovation and the
benefit to society as a whole). For pharma brings:
• loss of pricing freedom for new brands at launch.
• Potentially delayed access to market
• Uncertainty definition of ‘value’ not yet defined
• To improve access to new medicines proposal that all NICE recommendations
would automatically be adopted into local formularies.
• Until 2014 manufacturers can continue to enter into ‘risk-sharing’ agreements
to secure positive recommendations from NICE.
• For unbranded generics, the contractual framework for community pharmacy
will continue to compare prices of groups of generics to make reimbursement
adjustments for around 500 drugs, so that excess profits by pharmacists
above an agreed amount, can be clawed back.
Hinweis der Redaktion
No going back
More than half of babies born in industrialized nations since the year 2000 can expect to live past 100
Demand 6% year, Funding ~ .1% - spending review efficiency savings (20 billion) to 2015 2015 return to funding growth (?) – gap has developed But Treasury AME (pensions, debt interest, unemployment etc - increasing 1.8%/year DEL (department expenditure limits) – health, schools, prisons, defence, etc fall 3.8% realterms current efficiency equivalent to 2.3%
Over the next five years funding of £4.7 million will be allocated for raising awareness for diseases such as cancer, diabetes, obesity.( areas where the UK performs less well than other OECD countries) Early diagnosis and screening of patients will drive up demand for medicines. New Health and Welfare Boards, local councils will have a role in promoting public health and from April 2013 will be allocated a budget to spend on disease prevention measures. Programmes to reduce morbidity and mortality from cardiovascular disease, now recognised as having achieved considerable success, will be pursued. emphasis on patient choice, patients having a much wider choice of provider. From April 2012, patents referred by GP able to choose from providers from the NHS, private or voluntary sector. So far, this choice has been restricted to non-urgent care such as elective surgery. Personal Health Budgets pilot programme is currently underway to test out personal health budgets in the NHS in England - give patients with conditions such as diabetes, stroke or chronic pain direct payments to allow them to decide how and when they receive their healthcare. From 2014, everyone qualifying for continuing health care will be entitled to a personal health budget. New committee to cut NHS medicines wastage-around £200 million is wasted in unused prescriptions + £500 million a year from patients not taking their medications correctly. As part of cost-containment measures the number of drugs issued per prescription could be limited from, for example, 56 to 28 days’ supply Restrictive prescribing: From September 2012, through prescribing analysis and cost tabulation (PACT) data, GPs will be able to compare prescribing habits among other GPs in the same primary care organisation. Under the GP contract, practices will be rewarded financially for provision of quality care measured against specific indicators, by using Quality and Outcomes Framework. By encouraging diagnosis and prescribing, this would increase volume and cost but the emphasis will be on generic prescribing and dispensing. Value-based pricing framework proposals for new branded medicines in 2014. here will be greater collaboration between primary and secondary healthcare professionals under integrated care. Financial pressure on hospitals looks set to result in mergers and perhaps more failing NHS hospitals being run by private companies. home care market, now valued at over £1 billion, growing rapidly and will offer opportunities for manufacturers with innovative new medicines such as chemotherapy and rheumatoid arthritis treatments. A more co-ordinated approach by NHS bodies to the supply and purchasing of home care medicines can be expected. Clinical Commissioning Groups fully operational by April 2013. NHS budgetary responsibilities will be transferred to the CCGs who will have control of purchasing health services from private as well as NHS providers Greater competition expected between public and private providers and the CCGs will be under pressure to maintain low expenditure less emphasis on meeting specific targets and more attention placed on clinical outcomes. Patient safety will be a priority. Quality standards, developed by the National Institute for Health and Clinical Excellence (NICE) will be the basis for commissioning of all NHS care and payment systems part of the planned shift in emphasis from targets to outcomes, NHS will have to reduce premature mortality from illnesses such as cardiovascular disease and cancer and improve the quality of life for patients with long-term conditions as part of a new NHS Outcomes Framework unveiled by the government in December 2010. There will be closer scrutiny of the outcomes delivered by the NHS and greater accountability for NHS bodies
Emphasis will be place on clinical outcomes and much less on meeting specific targets, under a new Outcomes Framework unveiled by the government in December 2010. The reforms will provide NICE with an important role in improving health outcomes and in pharmacoevaluations of new drugs. To improve access to new medicines the prime minister put forward a proposal in December 2011 that all NICE recommendations would automatically be adopted into local formularies.
Financially-based: where the list price remains unaltered but the company offers discounts or rebates, linked for example to numbers of patients treated, number of doses required, or responses of patients; and • Outcomes-based: involving the proven or expected value of a drug. Patient access schemes are attractive to manufacturers because they enable a reduction in the product’s price to the NHS without affecting the list price, and thus tend not to compromise the price that may be used by other countries in their international price comparison schemes. Personal Health Budgets pilot programme is currently underway to test out personal health budgets in the NHS in England - give patients with conditions such as diabetes, stroke or chronic pain direct payments to allow them to decide how and when they receive their healthcare. From 2014, everyone qualifying for continuing health care will be entitled to a personal health budget. Pharmaceutical industry/NHS joint working arrangements are still relatively rare, despite guidance from the Association of the British Pharmaceutical Industry (ABPI) and the DH, according to NHS PCC. The ABPI and DH developed a 'toolkit' in 2008 to encourage NHS organisations to consider joint working as a realistic option for the delivery of high-quality healthcare and a way to drive efficiency in the delivery of services in both primary and secondary care. NHS chief executive David Nicholson, chief executive designate of the new NHS Commissioning Board, suggests that the Board should develop a relationship with industry, including pharmaceutical suppliers, which would support its "strategic approach to innovation and development". Also, the secretary of state for health will have a statutory duty to promote research, and CCGs will be obliged to encourage research, innovation and the use of scientific evidence through their decisions. The original legislation had been criticised for not encouraging doctors to make more use of more advanced treatments and clinical innovation. Some CCGs are already looking to pharmaceutical companies to help them achieve better patient outcomes within their budgetary constraints Copayments Patients who pay privately for expensive new medicines not reimbursed by the NHS do not lose NHS reimbursement for other aspects of their care. This will encourage patients who can afford it to pay out of pocket for expensive new drugs not recommended for prescribing under the NHS, although these patients are very much in a minority. Leading supermarkets are offering certain medicines at cost price for those paying privately. Patient access schemes continue to be favoured by companies keen to ensure a positive recommendation from NICE. The planned introduction of value-based pricing for new brands could put an end to these schemes after 2013, although the DH has indicated that there may be a case for retaining some types of patient access scheme. NHS organisations are said to be expanding the number of products restricted to prescribing by a hospital consultant ('redlists'), Another cost-containment measure reported recently is limiting the number of drugs per prescription – for example from 56 to 28 days' supply NSFs include: hypertension; stroke; COPD; diabetes; coronary heart disease; renal disease; children; older people; long-term conditions, with a particular focus on neurological conditions; and mental health Non-doctor health professionals have gained prescribing rights in the UK. Pharmacists and nurses qualified as ‘independent’ prescribers can prescribe any licensed medicine for any medical condition within their competence. Pharmacists can prescribe independently for products to control blood pressure and diabetes, for example, while specialist nurses (eg those running clinics for certain chronic diseases) can also prescribe There are opportunities for pharmaceutical companies to work with GP practices to help them meet the demands of the QOF – for example, supplying patient education materials, business training, provision of outcomes data – and several are already doing so in areas such as COPD. Early indications from some of the new CCGs are that they would welcome industry involvement ranging from redesign of clinical pathways to education programmes. quality standards, developed by NICE for the NHS Commissioning Board. These will set out each part of the patient pathway and indicators for each step. Quality standards published by the end of 2011 included: stroke; dementia; prevention of venous thromboembolism; breast cancer; adult diabetes; chronic kidney disease; chronic heart failure; COPD; depression in adults; glaucoma; end-of-life care; alcohol dependence; and neonatal care. Further clinical areas identified for inclusion in the programme are: asthma, bipolar disorder, osteoarthritis, gastro-oesophageal reflux disease; hepatitis B; and various cancers. NICE expects to produce 150 standards within the next five years.
Chronic diseases : Biggest cost drivers to system are care-related: chronic care, exacerbations, hospitalisation Requires services/solutions that minimize cost of care and keep patients out of hospital Speciliaty Care Biggest cost drivers to system are drug-related and are unpredictable: in-patient drugs, drugs for complications/ exacerbations, prophylaxis Requires risk sharing/ flat pricing, targeted therapies to ensure that pharmaco has efficiency incentives
Government will introduce measures to ensure that NICE guidance is adopted rapidly and equitably across the NHS in England, provide an early access scheme for certain new medicines, offer new incentives to encourage R&D in the UK, and halt disinvestment and the decline in clinical trials. Under VBP, which will (like the PPRS) apply across the UK, manufacturers would propose an NHS price for their new medicine which would then be assessed on the basis of its value, looking at patient benefits, unmet need, therapeutic innovation and the benefit to society as a whole. It will apply only to new branded prescription drugs as it would not be feasible to carry out a value-based assessment for each medicine already on the market. Thus, VBP would affect new medicines launched after 1 January 2014 – approximately 30 drugs per year. The government believes that VBP would encourage innovation as it would discourage companies from developing drugs for which added-value could not be demonstrated (eg 'metoos') but there are concerns about whether this is a realistic expectation, and also whether the NHS should subsidise this by paying extra for innovative medicines. "We still have reservations about the impact the proposals will have on driving innovation. We remain concerned about the difficulty in defining what innovation is and whether (NHS) commissioners should pay a premium for innovation." (NHS Confederation Official) The vast majority of branded medicines already on the market before 2014 will be covered by successor arrangements, which have yet to be decided. The DH has indicated that it is still considering the possibility of a small number of existing drugs being assessed under VBP on a case-by-case basis. Potential candidates might include: major new indications for existing drugs; drugs considered but not recommended by NICE; some drugs funded through the Cancer Drugs Fund; and drugs recommended by NICE where current guidance is due for review. Under VBP, a range of thresholds – effectively maximum prices – would be set for new medicines. The DH proposes that the price threshold structure be determined as follows: • A basic cost-effectiveness threshold reflecting the benefits that would not be gained elsewhere in the NHS if the funding were to be used for the medicine. • Higher thresholds for medicines to tackle diseases where there is a greater ‘burden of illness’ – the more the medicine is focused on diseases with unmet need, the higher the threshold. • Higher thresholds for medicines that can demonstrate greater therapeutic innovation and improvements when compared with other products. • Higher thresholds for medicines that can demonstrate wider societal benefits
