Senators Seek to Prohibit Step Therapy for Stage 4 Cancer Patients

Uncategorized  |  December 10, 2019

Senators Seek to Prohibit Step Therapy for Stage 4 Cancer Patients

Health insurance companies would no longer be allowed to utilize the step therapy process for stage 4 cancer patients under legislation proposed by Sens. Bob Hackett (R-London) and Hearcel Craig (D-Columbus).

The bill, which has not yet been introduced, would require insurance providers in Ohio to eliminate “fail first” provisions that require patients to first try an insurer’s preferred drug prior to receiving financial coverage for the therapy prescribed by a treating physician.

“We know insurers frequently use fail first policies, or actually as we call it, ‘step therapy,’ to require certain treatments where they often use less expensive, generic medications as a first-line treatment. Many times, actually, I’ve supported this process. But however, we know that patients diagnosed with stage 4 metastatic cancer do not have the time to fail first on cancer therapy drugs before getting the best therapy for their type of cancer,” Hackett said during a press conference at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC James) on Monday.

“The impact of this legislation should be minimal, because we are not asking health plans to cover a drug that they normally would not cover. We are asking the plans to remove the additional burden placed on stage 4 cancer patients to fail on another drug first if they’ve been prescribed a different therapy that an oncologist believes gives them the best chance for survival,” Hackett said. “Many times, these new therapies are more costly up-front, and we admit that. But it can save cost over the long haul … older therapies can result in higher medical costs from delaying treatment … or more side effects which require care and possible hospitalization.”

Hackett said his longtime aide, Stephanie Kaylor, passed away from cancer last week.

“She fought a great battle. With everyone’s permission, I hope that we will name this legislation after Stephanie, because she really fought this,” Hackett said. “To be honest, we kept hoping Stephanie would pull through. … We were looking at it like she was going to make it. So it’s been a tough week. It’s like losing a daughter.”

Hackett said step therapy was not an issue with Kaylor’s treatment, noting she was going through the separate clinical trials process.

Craig said the bill will remove barriers for patients already facing the most difficult time in their lives, noting his mother had stage 4 cancer and his wife also had cancer.

“With all the tough physical, emotional and financial challenges facing stage 4 cancer patients, they do not have the time to fail first on cancer therapy. I hope that our bill will help ease some of the suffering that cancer patients and their families experience when they are expected to fail first,” Craig said. “We trust our physicians, like the experts here at the OSUCCC James to provide the treatment that will work best for each individual person.”

OSUCCC James Director Dr. Raphael Pollock said patients with stage 4 cancer don’t have time to wait for the best therapy.

“It’s important to bear in mind that although many stage 4 patients are beyond cure, there are also many patients with stage 4 disease, if treated appropriately, will still be able to enjoy cure or many years of high-quality time that are free of symptoms interacting with their families and colleagues and remaining gainfully employed,” Pollock said. “Fail first provisions do a real disservice to patients. They force them to go through therapies that are no longer the very best possible treatments for their disease. When we graduate from medical school, we take the Hippocratic oath, which is a solemn pledge, and the first commandment in that oath is, ‘Physician do no harm.’ That implies that we are always going to be looking for ever more effective therapies, hence the need for this bill.”

Pollock, who noted he is also a cancer patient, said oncologists want to offer the best treatments possible to each individual facing their unique cancer.

“One of the most exciting aspects of being an oncology care physician at this point … is the molecular revolution that is taking place. We know now so much more about the specific molecular targets that might provide therapy for patients in the future. Not all of these are standards of treatment yet, because they are in such rapid evolution and movement from the research laboratories across the street to the clinical arena over here on this side of 12th Avenue,” Pollock said. “We want to be able to offer very specific treatments for very specific diseases that affect very specific patients. This bill will go a long way toward enabling us to do that, particularly for the most vulnerable patients — those that have extensive disease.”

David Cohn, chief medical officer at OSUCCC James, also emphasized that cancer treatment is becoming more personalized.

“Cancer is no longer defined solely by where it started or where it is in the body, but rather by its biologic and genetic makeup. We now practice precision oncology, where treatment is tailored to the specific characteristics of that patient’s cancer. These new therapies directly target the biologic changes of the cancer cells, and spare the surrounding healthy tissues, often with fewer side effects that the patients experience,” Cohn said. “As new therapies come online, it’s critical that treatment and decision are made by oncologists with the knowledge about the patient’s condition and the makeup of their cancer, and not by insurers only looking at potentially upfront costs.”

Cohn said he has personally treated patients that have suffered under their insurance company’s fail first policy.

“As a practicing oncologist, I’ve seen firsthand patients whose conditions have deteriorated while on cancer treatments that were not recommended for that patient. The chemotherapy that I recommended, for example, was denied by a patient’s insurance company despite appeal. Thus, an alternative chemotherapy was used, and during her treatment the patient’s condition declined and her quality of life worsened, an outcome that nobody wants. Unfortunately, this example is not rare. Patients have been denied medications recommended by their oncologists, which could have improved their outcome. For a patient, living to see an important milestone like her daughter’s wedding, or the birth of her grandson, is critically important.”

According to Ohio State University, studies show tailored treatments are resulting in better cancer control and fewer side effects for patients who qualify for molecularly-driven, targeted therapies. Approximately 20 percent of patients diagnosed at the OSUCCC James have stage IV disease, meaning that their cancer has advanced beyond the primary organ site and into nearby tissues, lymph nodes, organs and other areas of the body.

The states of Texas, Georgia, Delaware, Connecticut, Illinois, Minnesota, Louisiana, Arkansas, Colorado, Maryland and North Dakota have already passed legislation similar to that proposed by Hackett and Craig, according to Ohio State University.

Under the legislation, insurance providers would be required to provide immediate access for medicines that meet one of the following three criteria:

– Approved by the U.S. Food and Drug Administration (FDA) for treatment of cancer and associated conditions.

– Included in the National Comprehensive Cancer Network (NCCN) drugs and biologics compendia for treatment of the disease;

– Supported by peer-reviewed medical literature as best practice for the treatment of stage 4 disease.

Hackett said lawmakers are still discussing some elements of the bill, including potential penalties for an insurer’s failure to remove fail first provisions. He said he’s been working with the insurance industry, noting he’s hopeful they will be an “interested party” on the bill, and not an opponent.

In an emailed statement, Ohio Association of Health Plans (OAHP) President and CEO Miranda Motter said, “OAHP looks forward to continued conversation with Sens. Hackett and Craig, and we stand ready to review the language upon introduction.We look forward to understanding how the bill will enhance the comprehensive ‘fail first’ step therapy reform legislation recently passed by the Ohio General Assembly.”

The House added elements of step therapy bills 132-HB72 (Johnson-Antonio) and 132-SB56 (Lehner-Tavares) into 132-SB265 (Dolan) during the last session. Former Gov. John Kasich signed 132-SB265 in January 2019.

Story originally published in The Hannah Report on December 9, 2019.  Copyright 2019 Hannah News Service, Inc.