Expanded coverage for off-label uses of prescription drugs becomes law

STATE HOUSE — Legislation introduced by Sen. William A. Walaska (D- Dist. 30, Warwick) and Rep. K. Joseph Shekarchi (D-Dist. 23, Warwick) to provide Rhode Islanders expanded coverage for experimental uses of prescription drugs has become law. The measure was signed by Gov. Gina Raimondo.

Rhode Island law requires insurers to cover “off-label” use for drugs to treat cancer, provided the drug is approved for another use by the FDA and there is peer-reviewed medical literature to back its use for the patient’s condition.

The legislation (2016-S 2499A, 2016-H 7512), introduced at the behest of Attorney General Peter F. Kilmartin, now extends that law so that it applies not only to cancer patients, but to those with other disabling or life-threatening chronic diseases.

For Senator Walaska, the battle has been a personal one. He is currently recovering from his second fight with chronic lymphocytic leukemia (CLL), a rare blood and bone marrow disease that is a type of non-Hodgkin lymphoma. Efforts to fight the cancer with chemotherapy last fall were ineffective, and as he continued to decline, doctors at the Dana-Farber Cancer Institute were concerned about their limited options.

That’s when doctors at Dana-Farber and the Miriam Hospital suggested he try the cancer drug Imbruvica, which is already approved by the FDA for some patients with his condition, but is still the subject of some studies. And the improvements began “almost overnight,” he said. Since he began taking Imbruvica, Senator Walaska said his cancer is shrinking, he feels better and he has gained back about 25 of the pounds he lost.

“My own experience has shown me that experimental drugs can save a person’s life. I’m extremely lucky that I was able to access the drug that turned my health around when chemotherapy couldn’t,” said Senator Walaska. “I’m gratified that we have now written this into law. We shouldn’t say some life-threatening diseases warrant this coverage but others don’t.”

He added that, since New England is home to many universities and medical facilities that conduct medical research, Rhode Islanders might be uniquely poised to benefit from the expanded coverage, since their doctors might be connected to ongoing research and be more aware of drugs uses that are still being reviewed.

Senator Walaska said of all the bills he has introduced this year, this one might be the most important to him, because he can see why it could make a very important difference to some Rhode Islanders’ lives.

Representative Shekarchi echoed that sentiment: “This legislation is vital to Rhode Islanders who are seeking nothing more than an effective treatment for their health.  It is wrong to deny someone medicine that works if the medicine was not initially developed to treat certain diseases and conditions,” he said. “Breakthroughs and new discoveries happen constantly within the prescription drug field and it is important we do not let sick people suffer by denying them effective medication because the labeling and directed uses of a certain drug are not up to date with the current medical data.”

Attorney General Kilmartin said, “This legislation will go a long way to help patients suffering from life-threatening chronic diseases by ensuring they have access to the medication they need to live comfortably and pain free. In Rhode Island, the use of off-label medication to treat cancer has been required of insurance companies since 1994. The passing of this important legislation not only highlights the dramatic medical advances made since 1994, but makes them financially accessible for all Rhode Islanders. Obtaining FDA approval for medication is a lengthy and expensive process, and Rhode Islanders with chronic, disabling, or life-threatening illnesses should not have to refuse treatment because medical data is not updated.”

 

Source; http://www.rilin.state.ri.us/pressrelease/_layouts/RIL.PressRelease.ListStructure/Forms/DisplayForm.aspx?List=c8baae31-3c10-431c-8dcd-9dbbe21ce3e9&ID=12055&Web=2bab1515-0dcc-4176-a2f8-8d4beebdf488