ASCO releases value framework for assessing value of cancer drugs

It’s no surprise that costs of cancer drugs are high.  Recent estimates put the average cost of cancer drugs at $10,000 per month with some therapies costing as much as $65,000 per month.  If it weren’t for insurance, prices this high would put cancer drug therapy out of reach for most families.  Even with insurance, many families cannot afford cancer drugs because of high patient cost sharing.  Many insurance programs, such as the Medicare Part D program, set patient cost sharing as a percentage of the drug’s cost (usually in the 20% to 30% range) rather than as a fixed dollar amount.  Medicare Part B, which covers most injectable cancer drugs, has a patient cost share of 20%.  How many families can afford cost sharing of $2,000 to $3,000 per month?

Oncologists and their professional organizations are concerned about this and have taken steps to address the problem.   The WSJ  recently reported that Memorial Sloan Kettering Cancer Center has developed an on-line, interactive tool to help physicians and patients determine what cancer drugs are worth.  I will discuss this tool in next week’s post.  Today’s post will discuss a value framework for assessing the value of cancer drugs that was recently announced by the American Society of Clinical Oncology (ASCO),  the professional organization representing oncologists.

The ASCO value framework

The goal of the ASCO framework is to “provide a standardized approach to assist physicians and patients in assessing the value of a new drug treatment for cancer as compared with one or several prevailing standards of care”.  There are two versions of the framework: one for treatments of advanced cancers and one for treatments that are curative.  ASCO notes that the framework is a work in progress – “it is not yet suitable for use during a routine clinical encounter” and they have requested public comments on it.

The framework compares the clinical benefit, toxicity, and cost of cancer therapies.  A “Net Health Benefit (NHB)” score is calculated based on clinical benefit and toxicity.  The developers of the framework used evidence from high-quality prospective clinical trials to estimate the clinical benefit and toxicity scores.  The clinical benefit score is based on improvement in survival or, if survival data are not available, on the percentage of patients responding to the treatment compared with the current standard to treatment.  The score for clinical benefit can range from 0 to 130 points for treatments for advanced cancers and from 0 to 100 for curative treatments.  Higher scores indicate greater benefits.

The clinical benefit score is then adjusted for toxicity to calculate the NHB score.  The toxicity score adds or subtracts up to 20 points depending on how well the new therapy is tolerated compared with the current standard of treatment.  Drugs used for treatment of advanced cancers can get up to 30 bonus points.   These are awarded if the drug significantly reduces cancer-related symptoms or if it allows the patient to have treatment-free intervals.

Value is determined by comparing benefit to cost.  Benefit is measured by the NHB.  The framework includes two types of cost: drug acquisition cost and cost to the patient.  Surprisingly, it does not include other measures of treatment costs such as physician or hospital costs.

The framework does not provide a summary value score.  Instead “[t]he NHB and cost information are provided at the end of each framework as the summary assessment, with value being inferred through the relationship between NHB and the cost incurred to achieve that degree of benefit.”

Examples using the value framework

ASCO presents several examples that illustrate use of the framework.  One group of comparisons is for four relatively new first line treatments for metastatic non-small-cell lung cancer.  At one end of the value spectrum, the new treatment (cisplatin plus pemetrexed) shows no NHB compared with the current standard of therapy (cisplatin plus gemcitabine) yet costs nearly $3,000 more per month.  On the other end of the spectrum, erlotinib has a NHB of 44 out of 130 points based on longer survival and lower toxicity than the current standard (cisplatin plus docetaxel or cisplatin plus gemcitabine) but costs over $8,000 a month more than the current standard of therapy.

 

What’s next?

The framework is an impressive tool.  It’s based on high-quality evidence from clinical trials, it considers the costs and benefits of the new treatment in comparison of those of the current standard of therapy (as opposed to placebo), it was developed by oncologists, and the NHB scores are based on criteria that should be most important to oncologists and patients.  And, as ASCO, states, it is a work in progress.  But several questions occur to me regarding its ultimate success:

  • Will oncologists use the framework? Are cost and value issues that oncologists want to raise and feel comfortable raising with patients?
  • If oncologists do use the framework, will that have an effect on cancer drug pricing?
  • As reimbursement moves from fee-for-service to bundled payment and pay for performance will oncologists be more likely to use the ASCO value framework?  Under the current fee for service system, they have no financial incentive to dissuade them from trying drugs that show little benefit over cheaper therapies.  But with bundled payment or pay for performance system, the oncologist has a strong financial incentive not to try a high cost, low incremental benefit drug.
  • Will patients and oncologists need some point of reference for interpreting the NHB and cost data? It’s pretty clear that a drug with no NHB should not cost more than the current treatment, but it’s not as clear whether a drug with a NHB of 44 is worth an additional $8,000 a month.
  • Will ASCO continue to develop the framework and devote the resources necessary to update it as new treatments are developed and as new information for existing treatments becomes available?

In any case, providing a tool that encourages physicians and patients to talk about the value of high-priced drug therapy seems like a step in the right direction.