Sunday, July 17, 2016

Decisive Action Needed to Increase Patient Access to Hepatitis C Treatment

Despite the approval of effective hepatitis C virus (HCV) treatment regimens, the exceedingly high cost of the medication prevents it from reaching HCV patients, according to new research from Weill Cornell Medicine. Physicians and government officials must lead the development of a national consensus, enjoining the commitment of pharmaceutical companies and insurers to lower prices and remove restrictions so that patients can combat this difficult disease.
Dr. Brian Edlin
"In the last few years, two major historic developments have occurred," said Dr. Brian Edlin, an associate professor of medicine at Weill Cornell Medicine. "One is the development of HCV drugs that have revolutionized care and can eliminate this disease. The second is the collusion of decision makers at the heads of large organizations to prevent the drugs from being used to stop the epidemic. We need to seize the opportunity to overcome these man-made obstacles."
A review article, authored by Dr. Edlin and published July 12 in The Lancet Infectious Diseases, examines the current landscape of HCV, a virus that results in chronic liver disease and affects more than 3 million people in the United States.
Treatment regimens that eradicate HCV were approved in 2014; however, far too few patients have been able access the medication due to the tremendous cost. The treatment is priced from $83,320 to $150,000 for a 12-week course of daily pills — 84 pills in total. A separate study found that the cost to produce one pill was just $1.20. While there are significant overhead and research costs, pharmaceutical companies are still making an enormous profit, Dr. Edlin said.
Pharmaceutical companies have offered discounts, although the amount and frequency of these discounts remain undisclosed to the public. Nevertheless, public and private insurers are still unwilling to cover the steep cost. Therefore, insurers have limited the patients who can receive coverage to those with advanced liver disease, fibrosis and cirrhosis. "These restrictions are a violation of insurers' responsibility to cover lifesaving medications for their beneficiaries, imposed solely in order to protect their own financial interests," Dr. Edlin said. "Insurers are not at liberty to simply drop coverage when it gets too expensive." Taking the drugs earlier would prevent patients from reaching these debilitating stages — which can also lead to death.
"Pharmaceutical pricing for HCV is unconscionable," Dr. Edlin said. "They are extortionist prices because the choice is really your money or your life. And the restrictions payers have imposed defy medical guidelines, lack scientific justification, and undermine public health efforts to stem transmission and end the epidemic."
As a solution, Dr. Edlin proposes that physicians and government lead development of a consensus process involving legislators, public health authorities, pharmaceutical leaders, clinical experts, patients and advocates to agree that barriers must be eliminated so that everyone who needs treatment is able to receive it. For example, pharmaceutical companies can lower prices and insurers can eliminate restrictions on coverage. Clinicians and advocates can unite to promote federal regulation, such as removing barriers in drug price negotiations, which would drive prices downward, and advocate for outreach to those at risk. Public health groups could then begin the task of reaching, testing, curing and preventing every case of hepatitis C. If each group took decisive actions like these, the HCV epidemic could be eradicated, Dr. Edlin said.
"Doctors, the government and the public have the power to change the situation, but they have to overcome the sense of resignation about this problem," Dr. Edlin said. "Hepatitis C treatment access can be solved in a heartbeat by decision makers at large organizations. And it needs to be solved in a heartbeat."

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