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Update: New testimony to USPTO on impact of gene patents

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Read our most recent testimony to the USPTO.

View the results of our survey for consumer and health care providers on access to genetic testing and second opinion gene testing.

Read our prior testimony to the USPTO.

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The awarding of an exclusive patent for the BRCA 1 and BRCA 2 gene to Myriad Genetics has adversely affected access to care and research specific to hereditary breast and ovarian cancer. In 2012-2013 United States Patent and Trademark Office (USPTO) conducted hearings to determine:

  • The impact that lack of independent second opinion testing has had on the ability to provide the highest level of medical care to consumers of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;
  • The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and
  • The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

You can read information on FORCE's prior testimony to the USPTO here.

In January, 2013, the USPTO requested more information and data from FORCE on:

  • insurance coverage of predictive cancer genetic testing
  • access to testing for consumers who are uninsured or underinsured
  • consumer and health care provider views on second-opinion genetic testing

In response to this request, FORCE conducted a survey for health care providers and consumers on the above topics. In February 2013 we submitted updated testimony to the USPTO based on these results.

Summary of FORCE's recent testimony

You can view our full survey results here.

  • We are concerned about continuing gaps in access to genetic testing including
    • Many people who meet national expert guidelines for genetic evaluation lack access to cancer genetic testing due to inadequate or no health insurance coverage.
    • Over half of the healthcare providers indicated that at least 80% of their uninsured and underinsured patients are unable to access genetic testing through other means such as participation in research or via financial aid.
    • Medicare policies are not in alignment with national expert guidelines. Medicare does not cover the cost for genetic testing for BRCA for women who have not had cancer. Medicare also denies coverage of BRCA testing for men.
    • Only a small percentage of people who are denied genetic testing by insurance proceed with testing by paying out-of-pocket.
  • Our survey indicated that 60% of healthcare professionals and 35% of patients who underwent testing for a gene mutation would like the option of a 2nd opinion/verification genetic test.

Select survey comments from health care providers

  • "I have been a Board Certified Genetic Counselor specializing in cancer for over 20 years. Myriad's exclusive patent has prevented many of my patients from being able to access testing (due to the high cost - about triple what it is in Canada and Europe), and certainly has prevented the option of repeat confirmatory testing in another lab."
  • "My high risk clinic experiences substantial payor denials for reflex BART testing in appropriate clients. In my opinion, the current costs for multisite3, single site, comprehensive and BART testing are EXCESSIVE set by a purely profit-motivated company with no other alternatives available (globally). There is essentially no comparable testing permitted in the industry (because of patent protection) to provide price competition."
  • "My main issue with the BRCA gene patent is that other laboratories offering the recently developed "panel" testing (comprehensive analysis of multiple genes using next generation sequencing techniques) cannot include these 2 genes in their panel. So if I see a patient with apparent hereditary breast cancer, s/he cannot be tested for a comprehensive panel of breast cancer genes with one test. We have to rule out BRCA first, for $3400, and then order an additional $3000-$4000 worth of testing to rule out other genetic causes. It is time and cost prohibitive. It also does not make sense that full sequencing of a panel of 20 genes costs $3000 but similar analysis of only 2 genes (BRCA1 and BRCA2) costs more! Furthermore, most insurance companies will not cover the additional panel testing because they have already covered BRCA testing and the CPT codes are the same. This problem does not exist for other hereditary cancers such as colon cancer, because you can order one comprehensive panel that includes all of the currently known colon cancer genes. As long as a lab who has the patent on a gene does not have to compete with another lab for business, these costs will never come down and our patients and our healthcare system will suffer."
  • "I also believe the Medicare population is underserved by the guidelines established by CMS - they are not for prevention. Therefore, there are many unaffected and affected individuals with cancer who meet national guidelines for testing, but not Medicare criteria for coverage. The cost of testing is too prohibitive for them to pay out of pocket. Therefore, this can lead to less informative individuals in the family (such as daughters of a mother with bilateral breast cancer >50 yo) undergoing testing and having their insurance pay for testing. This can lead to wasted healthcare dollars when the most informative individual in the family cannot be tested due to insurance and cost limitations."
  • " We are moving to gene panel testing for many families that do not appear to be straight forward BRCA families. We are able to look at 10-15 genes linked to breast cancer with one test that is approximately $2500-$3500 yet these panels cannot include BRCA1/2 due to the patent. We must then run a separate $3400-4000 test to look at BRCA1/2. This is an unneccessary added expense that would not exist today if the patent were not in existence."

Select survey comments from consumers

  • "Medicare would not pay for genetic testing because I am male. I have daughters and nieces for whom the test results could be very important."
  • " I was tested for the BRCA 1 gene and the results came back positive so I then had prophylactic bilateral mastectomy and total hysterectomy. I have always wondered...what if the results were wrong? I would hate to think that I had all of this extreme surgery and I was not a carrier. That thought frightens me."
  • "This information is vitally important for people who may be high-risk. Please do everything you can to ensure that the people who need the testing have reasonable access to it."
  • "I would like to tell by descendants if I have the BRCA1 and/or BRCA2 mutations so they are aware. So far my insurance has refused to supply any criteria used in determining the need for the testing. The huge cost of the testing is beyond my ability to pay for the testing. It has been a very frustrating experience trying to get answers and/or responses from the various parties. My daughter went for genetic counseling about the matter and was told I should be tested based on the results of her tests."
  • " Testing was extremely expensive and I have a large family. We all paid cash and this was a hardship. Some of us pitched in money to pay for those who couldn't afford it. I am concerned about how many women have gotten tested without any genetic counseling prior... I think Myriad works to get primary care docs to test without counseling to increase their revenues. This is another ethical problem with Myriad's patent. Oh, and by the way...I own my genes. All of them. Even the mutated ones! Thank you."
  • " I'm concerned that the BART panel which has been recommended by two different medical teams
    (following my recent breast cancer recurrence) is not going to be covered by my insurer. The test is $700 which is prohibitive for me right now. I think the BART should be included within the larger BRAC Analysis and it doesn't make sense to me why it is not."
  • "Even with insurance, the test cost me $600 out of pocket. My daughter is paying $450 to only be test for BRCA2. I'm sure the cost puts the test out of reach for many who would benefit from it."
  • "Insurance would not pay for genetic testing or counseling although my father died from
    pancreatic cancer and I was told that I had breast cancer and was at risk of carrrying the BRCA
    mutation. I did test positive or BRCA2 and so my adult. children needed to be tested as well.
    Despite the recommendation of 2 physicians, a positive test in my father, and a history, I was
    denied coverage."
  • "My insurance said genetic testing was covered, but it only applied to my deductible - so I paid for the testing myself."
  • "Appealed three times before they paid."
Page updated 02/17/13

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