Challenges for biosimilar market access

Challenges for biosimilar market access – current and future


Given the recent changes to the biosimilar market over the last 5 years with the launch of multiple products, biosimilars are moving from novelties into the main stream. There is a perception that payers are trying to encourage faster access to biosimilars as they have the potential to offer broader access to innovative medicines and reduce healthcare savings. Does the evidence actually support this assumption?

Over the past few years, national payers have introduced biosimilar pricing policies which are less onerous than the pricing and reimbursement requirements for new chemical entities. For example, in UK NICE and SMC does not require a full HTA submission if the biosimilar price is lower than the branded product and access is only sought for indications previously approved by NICE or the SMC. In Germany biosimilars do not need to undergo an AMNOG assessment and are, essentially, considered the same as generics from a pricing perspective. In France, Italy and Spain there is an abbreviated pricing and reimbursement process if the biosimilar is price 25-50% lower than the originator product. Other national level policies have stimulated biosimilar uptake. For example, in Germany, the healthcare insurers have implemented multiple policies which has resulted in biosimilars achieving significant market share including tendered contracts, prescribing share quotas, and automatic pharmacy substitutions (which are strictly regulated, and for naïve patients only).

Other national biosimilar policies are creating unintended barriers to entry for biosimilars and have hampered efforts to shift market share towards biosimilars. For example, in Spain, an internal reference group may be created, which results in the reimbursed price being the same for biosimilar and the originator. This disadvantages the biosimilar as there is limited uptake, as physicians continue to prescribe the originator as there is no price incentive. Whilst capping reimbursement prices to biosimilar levels creates short term healthcare savings it does not encourage the uptake of biosimilars, and such policies could reduce competition over the longer term.

National ‘winner takes all’ tenders are another example where short-term healthcare savings can be recognised, but may have unintended consequences. One example is Norway, where the level of biosimilar discount 69% (for infliximab) and 47% (for etancercept) offered to win the tender creates significant short term cost savings. However, these discounts can set a dangerous precedent, both within the country and for other markets, as payers will come to expect them each year. It is unlikely that the biosimilars manufacturers will be able to maintain this level of discount over the longer term which, again, may result in reduced competitor (and higher prices) over the longer term. Also, whilst biosimilars undergo abbreviated HTA assessment, if the originator product was rejected, or had restricted patient populations for reimbursement, a full HTA process is mandated for the biosimilar. This can be a potentially costly and time resource intensive exercise.

Offering additional discounts to secure hospital access is common across the EU and can result in the actual net biosimilar price being less than 50% of the originator price. This can apply further financial pressure on biosimilar companies. These discounts can have a positive impact on patient uptake. For example, a study in Sweden showed that a discount of 30% was sufficient to place naïve patients on biosimilar anti-TNF. A 50% discount was required before hospitals actively encourage switching of existing patients to the biosimilar, indicating that a ~50% price discount is sufficient to entice both payer and physicians to use biosimilars.

Access barriers for biosimilars are also being observed at the local level. One of the main challenges is physician uncertainty over the value of biosimilars. Whist physicians recognise the need for healthcare savings, their predominant focus is on providing the best possible care to their patients. Unlike generics, physicians are generally encouraged to use brand names when writing prescriptions for biologics. For example, in the UK, the MHRA recommends that all biological medicines, including biosimilar medicines, are prescribed by brand name. The rationale is that biosimilars are not presumed to be identical in the same way as generic non-biological medicines. As such, brand name prescribing ensures that the intended product is received by the patient. This results in the choice of whether a patient receives a biosimilar or originator rests with the physician and pharmacists having to dispense the originator product, even if a lower cost biosimilar is available.

To overcome these barriers and ensure physicians feel comfortable in prescribing biosimilars, it is important to build trust in the clinical value of biosimilar. There two main areas of physician uncertainty regarding biosimilars. The first is for indications where there is no clinical data for the biosimilar, as they are usually approved by demonstrating comparability in only one indication, but they are licensed for all the indications of the originator biological medicine e.g. the use of biosimilar anti-TNFs for treatment of Crohn’s disease.

Biosimilar companies need to convince physicians that the biosimilar is equally effective but in a way that will not significantly increase costs (e.g. conducting additional trials which increases the cost for the biosimilar manufacturer and ultimately the price of the biosimilar). One potential way is to consider investigator initiated trials whereby manufacturers can build trust with physicians whilst at the same time developing a sufficient evidence base to demonstrate the comparability of biosimilars to the branded products. The second concern is regarding switching patients who are currently on the originator product to the biosimilar.  The results for the NOR-SWITCH study, which investigated patient outcomes of patients switching to biosimilars products and showed patient outcomes to be comparable will go some way to addressing this concern.

Whilst payers recognise the potential cost savings that biosimilars can provide and understand that it can broaden patient access to innovative medicines, work still needs to be undertaken to ensure that biosimilars can gain a foothold in markets and secure sufficient market share to ensure that the business model is sustainable. Payers need to consider the longer-term cost-savings of biosimilars, not just the immediate short-term budget savings that are on offer. Biosimilar manufacturers need to ensure that payers are well informed on the potential benefits of biosimilars and focus communication on the long-term healthcare savings of biosimilars. It will take time for physicians to feel comfortable using biosimilars. However, if the evidence generation continues, overtime, biosimilars have the potential to be considered comparable to generics (which also faced similar issues when launched) and offer healthcare benefits to a broader patient population whilst reducing overall healthcare expenditure.

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