PRMA Insights: The Roadmap to Pricing and Reimbursement Success

Psoriasis

Psoriasis is perceived by payors to have only cosmetic implications. As a consequence, it is given low priority in treatment funding agendas, making the pricing and reimbursement negotiations of innovative but expensive treatments a challenge. The reality for patients, however, is that psoriasis is a chronic and debilitating inflammatory condition that impacts heavily on health related quality of life (HRQoL).

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In 2008, the global psoriasis market was worth US$2.5 bn, 55% of which was attributed to biologics. The market is anticipated to grow by 40% by 2018, reaching sales of US$3.5 bn. The growth of the market is driven by a number of factors, including the unmet therapeutic need (currently there is no cure for psoriasis), the increasingly high prices of new biologics, and the absolute number of products in clinical development. This makes psoriasis a very attractive commercial opportunity for pharmaceutical and biotech companies, provided key market access challenges can be overcome.

The increasing cost of treating psoriasis has already attracted payors’ attention and will trigger the introduction of additional market access hurdles for biologics in the future. Some examples of payor hurdles to date include the risk-sharing agreement negotiated with NICE for the reimbursement of the 90 mg dose of Stelara at the same price as the 45 mg dose; the definition of targeted patients for treatment with biologics based on PASI and HRQoL scores and number of previously failed less-expensive treatments; restricting the prescribing and dispensing of biologics to specific centers; monitoring of patients on biologics in national registries. Moreover, assessment of the comparative effectiveness of psoriasis treatments has been included in the second priority wave of the Institute of Medicine in the US.

Gaining market access and achieving a price premium for a new biologic will require a compelling evidence-based payor value proposition and head-to-head comparative clinical data. Key decisions during the development process that will impact the pricing and reimbursement opportunity include the choice of comparator, the selection of patients included in the trials with respect to PASI scores and previously failed treatments, the inclusion of patient-reported outcomes, and the duration of the trials. Manufacturers launching a new product will have to generate an evidence package consistent with the manufacturer’s pricing and commercial ambitions, and will therefore need to plan for the market access challenges in Phase II or earlier. Failure to adequately plan for market access and evaluate the evidence requirements could significantly reduce commercial success. Reduced price, a smaller-than-planned reimbursed population, and extensive market access delays are all commercially disastrous consequences.

PRMA Insights: The Roadmap to Pricing and Reimbursement Success in Psoriasis unravels the complexity around pricing and reimbursement of biologics in the psoriasis market and delivers actionable insights to apply to your global product development program, in order to develop a robust evidence-based payor value proposition and achieve market success.

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