Proton center growth spurs need for payer efficacy studies

As proton cancer treatment centers expand, payers and providers may have to collaborate to expand the evidence base, to avoid the highly-expensive technology crowding out other investments.

The Midwest's first proton beam cancer therapy center is closing its doors amid ongoing efficacy questions and financial struggles. At the advice of an outside review committee, Indiana University Health is closing its proton therapy center early next year, once the current roster of patients have completed treatment.

IU Health's center was the nation's third proton treatment facility and the Midwest's first when it opened in 2004. It offered cancer patients the potential of more selective radiation treatment with fewer side effects, but ten years later, its clinical benefits remain unclear, its technology is slightly outdated and its finances seem unsustainable.

The proton therapy center operated on a deficit for most of its existence (consuming $3.5 million in 2013) and the 20-hospital system has little choice but to cut its losses, said Jay Hess, MD, vice president for university clinical affairs and dean of the IU School of Medicine

"Unfortunately," he said in a media release, "rapidly advancing technology and changes in the dynamics of cancer treatment have left us with a dwindling patient base and a facility that is many times more expensive to operate than most of our competitors in this field."

Since IU Health and other pioneers opened their facilities 10 years ago, the number of proton treatment centers has proliferated, with 13 now in operation across the country and 10 in construction, according to the National Association for Proton Therapy.

Meanwhile, the debate over proton treatment's effectiveness compared to traditional radiation therapies has grown only more murky, and more insurers, like Aetna and Blue Shield of California, have stopped covering it for malignancies such as prostate cancer -- perhaps the most controversial cancer in terms of the debate over benefits for aggressive treatment, and also a large source of revenue for proton therapy and cancer treatment centers in general.

The trouble for many payers with proton beam therapy is that the evidence supporting improved outcomes is not established, while the extra costs substantial -- garnering around $13,000 more from Medicare than intensity modulated radiation therapy.

But absence of evidence is not evidence of absence, and oncology researchers and advocates still hold hope for proton therapy across cancer types, particularly for pediatric cancers and cancers of the eye, brain head and neck. Rather than sparring over coverage, though, some insurers and providers are using the uncertainty as an opportunity to study proton therapy's comparative effectiveness.

In greater Philadelphia, two organizations are doing just that: Independence Blue Cross and Penn Medicine, the University of Pennsylvania Health System.

When Penn Medicine opened its proton center in 2010, it created a reference pricing agreement with Independence Blue Cross (IBC). The health system is reimbursed at the same rate for radiation therapy, regardless of whether an IBC-insured cancer patient receives proton therapy or other forms of radiation, while patient outcomes are being tracked in a registry to gauge long-term costs and benefits. New Jersey's largest insurer, Horizon Blue Cross Blue Shield, also covers proton treatment for members with prostate cancer who enroll in a randomized trial at Penn Medicine.

"Reference pricing with evidence development is attractive for proton therapy," as Penn Medicine oncologists Justin Bekelman, MD, and Stephen Hahn, MD, wrote recently in the Journal of Clinical Oncology.

Currently, "the price premium of proton therapy is not only untenable in the eyes of payers and patients but also an obstacle to evidence development," they argue. "Yet, we can conduct the necessary research only if payers pay for proton therapy and its photon-based alternatives. Reference pricing preserves access to proton therapy and reduces financial barriers to evidence development."

If providers are interested in opening proton therapy centers -- which exist in only 12 states currently -- they should "fund the difference between the reference price paid by insurers and the costs of proton therapy," Bekelman and Hahn argue.

Not only are private payers limiting reimbursement for proton radiation therapy, but public payers -- including some very large state ones -- are starting to as well.

The Washington State Health Technology Assessment Program, which determines coverage for certain high cost health services paid by Medicaid and the state employee health plan, recently decided to include proton therapy as a "covered benefit with conditions."

Based on a review of current evidence, the Assessment Program is limiting coverage to ocular cancers, pediatric cancers, central nervous system tumors and non-metastatic cancers with agency discretion.
Excluded are some of the most common cancers.

The Assessment Program's board found the evidence base "insufficient to determine net health benefit" for proton treatment of breast and gastrointestinal cancers and found that proton therapy is comparable though not superior to standard treatment options for lung and prostate cancers.