Expanding Molecular Testing: What Payers and Manufacturers Should Know
Medicine has been trending towards personalization for decades. The growth of individualized medicine and new diagnostic technologies has resulted in drugs that are tailored towards patients’ profile and condition—and are much more effective as a result. These therapies rely on the existence of molecular tests, including genetic testing, predictive and prognostic biomarkers, and companion diagnostics.
But how well are payers keeping up with this sea change? How are they managing new brands that utilize molecular testing to identify patient cohorts? How do they update management of established brands that now require new testing capabilities?
Let’s take a look at the current state of molecular testing to explore these questions further.
Types of molecular testing
Molecular-targeted therapies enable personalized treatment based upon a patient’s specific mutations, or in some cases, the lack thereof. Examples include protein inhibitors to treat HER2-positive breast cancers, tyrosine kinase inhibitors (TKIs) to treat leukemia patients with the BCR-ABL genetic abnormality, and monoclonal antibodies to treat patients without a RAS mutation.
While most of these drugs target a subset of patients with specific genotypes, some have the ability to be manufactured directly from cells from an individual patient, such as CAR T-cell therapies and CRISPR-based medications that use gene-editing technology.
Predictive tests, like those that categorize breast cancer patients based on ER, PR, and HR hormone status, lead to the conclusion that a specific drug is ideal for an individual patient. Prognostic tests, like Decipher, OncotypeDX, Prolaris, and Promark for prostate cancer, give providers information as to the severity of the patient’s disease. Imaging can serve both predictive and prognostic purposes, as can some genetic markers.
How payers use testing results
For payers, molecular testing serves many functions in policy development. Testing is primarily used to define which patients are eligible for a particular therapy, while repeated molecular testing (or imaging) can also be used to determine reauthorization. For example, a patient whose tumor has shrunk may no longer be eligible for the first-line therapy that generated those results.
Molecular testing can also be used to prefer one brand over another. For example, highly effective therapies in biomarker-specific cohorts may be preferred by payers over slightly efficacious therapies for an all-comer population.
Even for covered molecular tests, ensuring access for patients is not always easy. In a recent Drug Channels article on overcoming access barriers to biomarker testing, my colleagues explained why payers tend to default to generalized policies on biomarker testing and next-generation sequencing, without specifying eligibility criteria or the appropriate coding. Physicians are often unclear whether or not testing is covered for a specific patient scenario, which can lead to treatment delays.
Disparity in how payers react to label changes
Somewhat surprisingly, payer coverage for molecular testing does not need to align with the drug label, although often times it does. Payers can exclude testing even if it is listed on a product’s label; they can also require a certain test for the purposes of demonstrating patient eligibility even if the test is not listed on the label.
To complicate matters, every payer responds differently to label changes. Some payers respond quickly while others respond more slowly, and some do not respond at all. According to research from MMIT Analytics’ policy and restriction (PAR) data, as many as 20-30% of payers may never change their policies up to five years post label-change.
Differences in how payers react to label changes can be attributed to a number of factors, from misaligned P&T review cycles to the perceived importance of the change as it relates to anticipated shifts in utilization. If the label change receives media attention, payers are naturally more likely to update their policies accordingly. Payers also may not know about the label change in the first place.
This inconsistency between payers can pose a number of problems for patients. If new studies indicate that a medicine is only effective in a smaller subpopulation and the label is changed, legacy patients could still be taking the drug without realizing its limited utility for them. They also may not know to get the test that could identify a more effective potential treatment.
Key takeaways for payers and manufacturers
Given the increased prevalence of personalized medicine, both payers and manufacturers need to continuously monitor developments in molecular testing capabilities. Identifying and authorizing the right subclass of patients is an ongoing process, which should involve routine reviews of which molecular tests are appropriate for each therapy.
For new therapies, clinical trial design will become even more important for manufacturers’ market access teams. Payers are increasingly monitoring patient eligibility as defined by clinical trial populations, even if these segmentations are excluded from their respective label.
For already-established therapies, payers who fail to conduct regular reviews risk falling behind on the latest research. Consequently, they risk paying for clinically inappropriate patients to receive a therapy that will not help, and more importantly, they risk poor patient outcomes.
Meanwhile, manufacturers need to continuously monitor the latest research in predictive and prognostic capabilities to ensure their brands remain effective, innovative, and competitive. They also need to be aware that many payers do not update their policies due to label changes, and thus should consider their strategic imperatives when engaging with payers on this topic.
If a therapy’s label is now more restrictive, its manufacturer may not want to advertise this fact to payers. However, the manufacturer’s competitors may choose to launch a payer education campaign to ensure that more payers will revisit their eligibility criteria. Essentially, each manufacturer must decide for itself if engaging with payers to prevent label / policy misalignment is advantageous for its brand.
Learn how MMIT’s Analytics and PAR Insights can help you assess the impact of current payer policies and restrictions on your brand’s market position.
