Personalised therapies are becoming a reality, offering physicians and patients the opportunity to provide individualised treatment approaches for multiple diseases. A key component of personalised therapies is companion diagnostics, which enable physicians to identify patients who are most likely to respond to treatment thereby achieving maximal health benefits. Companion diagnostics also reduce the adverse effects and costs for patients who are unlikely to respond to the treatment.
In theory, therapies combined with companion diagnostics should be welcomed with open arms by payers as they allow a clinician to predict who will respond before a medicine is prescribed and any money is spent. Unfortunately, as a result of fragmented pricing and reimbursement systems for diagnostics across the EU, this is not currently the case, resulting in unequal patient access to personalised therapies.
Historically, pricing and reimbursement decisions for drugs and diagnostics have been carried out separately with varying degrees of rigor applied in such assessments. Typically, the pricing and reimbursement of a therapeutic follows a rigorous and transparent pricing and reimbursement process conducted at a national level. On the other hand, the pricing and reimbursement processes for companion diagnostics are less well defined with funding and patient access more focussed at the local hospital level where the cost of diagnostics must be absorbed within code-specific (DRG) fee schedules or hospital laboratory budgets.
There is considerable variability in the pricing and reimbursement process for companion diagnostics across the EU. The UK, through NICE, has been considered the gold standard for using evidence of clinical effectiveness and cost effectiveness to inform national guidelines for both pharmaceuticals and diagnostics. If the primary purpose of a companion diagnostic is to identify patients likely to respond to treatment, then the NICE assessment of the companion diagnostic is combined with the novel treatment in one assessment process. If the companion diagnostic is not linked to one specific therapy but has obtained a CE mark, then it is assessed by a separate NICE process known as Diagnostic Assessment Programme (DAP). Countries such as Belgium, France, Germany, the Netherlands, and Italy still have completely unlinked processes between evaluating the reimbursement of the companion diagnostic and the treatment.
The process for the assessment of the companion diagnostics is more opaque than the process for the treatment. It also involves different stakeholders, who often request different evidence to those stakeholders evaluating the therapeutic. This commonly results in significant delays in securing reimbursement for companion diagnostics and therefore a delayed patient access. In Spain, many budget holders at the regional and local level expect the pharmaceutical company to provide the companion diagnostic for free to enable patient access to the associated therapy.
The discrepancy between the separate pricing processes for therapies and diagnostics has resulted in large variability of coverage for personalised therapies across the EU. For example, trastuzumab – a drug used for the treatment of breast cancer where the HER-2 overexpression is present – is widely reimbursed across the EU since 2000, but reimbursement for its HER-2 companion diagnostic test varies. In the UK, Germany, and Italy, HER-2 testing is publicly funded, with France reimbursing HER-2 testing only since 2007. In contrast, in Spain, the pharmaceutical manufacturer funds the majority of testing.
The unpredictability of funding for companion diagnostics has created a barrier for manufacturers, who have no clarity regarding the necessary steps for value demonstration of the diagnostic that would lead to it being reimbursed. This ultimately has a knock-on effect on the therapeutic that is not going to be used until the physician knows which patients are likely to respond.
Until there are aligned pricing and reimbursement processes for companion diagnostics and the associated therapy, pharmaceutical companies must ensure that they have a clear understanding of the patient access processes for both the diagnostic and the associated therapy. This will involve the identification of all relevant stakeholders and will result in the collation of additional evidence required to support patient access for the companion diagnostic. In addition, to facilitate patient access at a local level, hospital managers will need to have an understanding of which budgets will be affected by introducing the companion diagnostic medicine, taking into account the local arrangement for financing laboratory and pharmacy services and being clear who is responsible for each respective budget.