By Hartmut Stecher, PhD, MS
Principal Scientist at Cancer Treatment Navigator, Inc.
Principal Scientist at Cancer Treatment Navigator, Inc.
 | Patient access to investigational cancer drugs is governed by the FDA, via clinical trials and the compassionate use program. The new senate approved bill “Right to Try Act”, provides a third new avenue to patients to secure investigational drug. The pros and cons about the “Right to Try Act” are debated in this Medpage article. |
Cancer Treatment Navigator (CTN) has intimate perspective on issues faced by cancer patients in accessing investigational therapies. Our personalized services identify treatments not yet considered for cancer patients diagnosed at any stage, after a complete review of their medical history and gene mutation profile. Often, these turn out to be drugs under study in clinical trials, and not available in clinics or hospital formularies. In our experience, patients continue to face difficulty in accessing these drugs because of factors such as physician opinion on when to keep trying and when to give up hope of improving a patient’s condition. Several hopeful patients that make informed choices on wanting to try an investigational therapy end up battling odds when their cancer care team, led by an Oncologist is unaligned on the benefit/risk profile of a drug that is in clinical trials, even though there is ample safety data to warrant its use.
One of the patients we served in the past had highly metastatic throat cancer. Scientific and clinical data supported that he might greatly benefit from a drug that is approved for a special form of lymphoma. This specific drug was “investigational” for metastatic throat cancer, yet had been on the market for lymphoma for almost a decade – with thousands of patients treated and a remarkable safety record. Yet, it was the Oncologist’s decision to refuse writing a prescription for this drug, citing concerns about the patient’s safety. The irony of this story was the fact that the Oncologist did sign the paperwork for “Death with Dignity”, but could not honor the wish of the patient to try one last “investigational” option with established safety before giving up.
This is one of the cases where CTN wholeheartedly supports a “Right to Try-Law”, with provisions to truly empower patients. We would have worked hard for this patient to secure insurance coverage for this investigational drug or work directly with the manufacturer to gain access to this medicine. Above all, the patient would have been willing to pay for a 2-month supply out of pocket – enough to assess if the drug is providing benefit – and still not too long that the patient and his family would have encountered financial hardship. The only “missing link” to gain access to this investigational drug was the signature of the Oncologist on the prescription. It should be the patient’s decision to try one more time, and not of one individual Oncologist. Oncologists play a pivotal role in providing proven therapies, but often do not have the bandwidth to research and assess numerous investigational drugs or get lost in paperwork and phone calls to try secure coverage of investigational drugs. In its current form, will the “Right to try Act” be able to make a difference? We believe there should be modifications on how to assess safety before it is passed into law, so that Oncologists have to define why they don’t accept an investigational drug’s safety, instead of a mere “yes” and “no” based on comfort level dictating a cancer patients right to try.
One of the patients we served in the past had highly metastatic throat cancer. Scientific and clinical data supported that he might greatly benefit from a drug that is approved for a special form of lymphoma. This specific drug was “investigational” for metastatic throat cancer, yet had been on the market for lymphoma for almost a decade – with thousands of patients treated and a remarkable safety record. Yet, it was the Oncologist’s decision to refuse writing a prescription for this drug, citing concerns about the patient’s safety. The irony of this story was the fact that the Oncologist did sign the paperwork for “Death with Dignity”, but could not honor the wish of the patient to try one last “investigational” option with established safety before giving up.
This is one of the cases where CTN wholeheartedly supports a “Right to Try-Law”, with provisions to truly empower patients. We would have worked hard for this patient to secure insurance coverage for this investigational drug or work directly with the manufacturer to gain access to this medicine. Above all, the patient would have been willing to pay for a 2-month supply out of pocket – enough to assess if the drug is providing benefit – and still not too long that the patient and his family would have encountered financial hardship. The only “missing link” to gain access to this investigational drug was the signature of the Oncologist on the prescription. It should be the patient’s decision to try one more time, and not of one individual Oncologist. Oncologists play a pivotal role in providing proven therapies, but often do not have the bandwidth to research and assess numerous investigational drugs or get lost in paperwork and phone calls to try secure coverage of investigational drugs. In its current form, will the “Right to try Act” be able to make a difference? We believe there should be modifications on how to assess safety before it is passed into law, so that Oncologists have to define why they don’t accept an investigational drug’s safety, instead of a mere “yes” and “no” based on comfort level dictating a cancer patients right to try.
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