MASSACHUSETTS MEDICAL SOCIETY HOUSE OF DELEGATES

 

 

Code: Resolution:  203, I-09 (B)
Title:    Consistency of Pharmaceutical Therapy

Sponsor:  Matthew D. Gold, MD

Referred to:   Reference Committee

Whereas, Improving health care quality, access, equity, and cost effectiveness for the Commonwealth and promoting a sound public health system are Massachusetts Medical Society strategic priorities; and

Whereas, Due to the necessity to control health care costs, a number of new initiatives from industry and government have been proposed with little input from practicing physicians; and

Whereas, Certain disorders (e.g., epilepsy) require consistency of pharmaceutical product, specifically bioavailability, from one manufactured batch to another, in order effectively to be controlled. (Bioavailability is a term that describes the rate and extent that a drug is absorbed, i.e., reaches the inferior vena cava or systemic circulation. Bioequivalence is the term for pharmaceutical equivalents that show similar bioavailability when studied under similar experimental conditions.  Blood levels for the generic and standard products should be very similar undefined the inference that equal blood levels of drug for both products result in equal therapeutic effects[1][1]; and

Whereas, In the opinion of many, mandated use of generic products results in prohibitive restrictions on access to, and costs for, consistently manufactured pharmaceuticals (usually in Branded form); and

Whereas, The difference, batch to batch, in bioavailability of generic products may be as high as 40% (by existing FDA regulation: “Code of Federal Regulation: Bioavailability and Bioequivalence Requirements”, vol. 21, Part 320, U.S. Government Printing Office, Washington, DC 20000) vs. 10% in the case of consistent (Branded) products; therefore, be it

RESOLVED, That the Massachusetts Medical Society (MMS) vigorously oppose any industry or government Initiative or existing requirement, proclamation and/or legislation that  contradicts the assessment of qualified medical practitioners, and thereby constrains the use of consistently manufactured pharmaceutical products where medical evidence categorically supports that use; and, be it further  (D)

RESOLVED, That the MMS Society increase its efforts to restore the practice of medicine in general, as it applies to treating patients exclusively to the direction of those trained and experienced in that practice, and so licensed.  (D)

 

 Fiscal Note:   No Significant Impact

(Out of Pocket Expenses)                         

FTE:    Existing Staff

(Staff Effort to Complete Project)

 

Background:

The House of Delegates, at its Annual 2010 Meeting, referred Report: 209, A-10 (B) to the

Board of Trustees (BOT) for decision.

The report states:

That in lieu of Resolution: 203, I-09 (B), Consistency of Pharmaceutical Therapy, the House of Delegates consider as a substitute the following AMA Policy D-125.989, Substitution of Biosimilar Medicines and Related Medical Products, adopted November, 11, 2008, which reads as follows, with a report back for action at I-10:

 D-125.989 Substitution of Biosimilar Medicines and Related Medical Products

 Our AMA will: (1) monitor legislative and regulatory proposals to establish a pathway to approve follow-on biological products and analyze these proposals to ensure that physicians retain the authority to select the specific products their patients will receive; and (2) work with the U.S. Food and Drug Administration and other scientific and clinical organizations to ensure that any legislation that establishes an approval pathway for follow-on biological products prohibits the automatic substitution of biosimilar medicines without the consent of the patient’s treating physician. (Res. 918, I-08)

 The Board forwarded this item to the Committee on Quality Medical Practice (CQMP) for a report back with a recommendation for BOT action at the October 6, 2010, BOT meeting. At A-10, the reference committee summarized testimony on Resolution: 209, A-10 (B) as follows:

 Your reference committee heard testimony in support of adoption or referral for decision of this resolution. While the report recommendation addresses the issue of biosimilar medications it does not address the full issue of bioequivalence raised by the original resolution from I-09. Therefore, your reference committee recommends referral to the Board of Trustees for decision.

 Current Status:

CQMP reviewed report 209, A-10 to obtain further background for this report:

At I-09, the House of Delegates (HOD) referred Item 2 of Resolution: 203, I-09 (B), Consistency of Pharmaceutical Therapy, to the Board of Trustees (BOT) for report back at A-10. The BOT referred Item 2 to the Committee on Legislation for a report and recommendation to the HOD.

 That resolution directed:

That in some circumstances and with certain disorders that require consistency of

prescription products, the decisions on any patient’s specific medications be made by

that patient’s treating practitioner. (D)

 On February 3, 2010, the Committee on Legislation discussed the issue of bioequivalency1 at some length, including the questions related to the availability of generic and branded products. The discussion included recognition of the need to create an expedited “pathway” to facilitate the Food and Drug Administration’s (FDA) approval process for biosimilars2, as well as on the need to assure that biosimilars are not substituted by pharmacists without the consent of the prescriber. While the FDA set the standard for drug interchangeability, states set the regulations regarding drug substitutions. The committee reviewed a policy adopted by the AMA on November 10, 2008, relative to this subject, as follows:

 D-125.989 Substitution of Biosimilar Medicines and Related Medical Products

Our AMA will: (1) monitor legislative and regulatory proposals to establish a pathway to

approve follow-on biological products and analyze these proposals to ensure that

physicians retain the authority to select the specific products their patients will receive;

and (2) work with the US Food and Drug Administration and other scientific and clinical

organizations to ensure that any legislation that establishes an approval pathway for

follow-on biological products prohibits the automatic substitution of biosimilar medicines

without the consent of the patient’s treating physician. (Res. 918, I-08)

 

The policy had been proposed by the following national medical specialty societies: the

American Academy of Facial Plastic and Reconstructive Surgery, the American Academy of Orthopedic Surgeons, the American Association of Neurological Surgeons, the American College of Surgeons, the American Society of Cataract and Refractive Surgery, the American Society of Plastic Surgeons, the 1 Congress of Neurological Surgeons, and the Society for Vascular Surgery.

The committee recommended that the House of Delegates review for adoption the above-cited AMA Policy D-125.989, Substitution of Biosimilar Medicines and Related Medical Products. However, the committee declined to make a recommendation regarding adoption of that policy.

Although the issues of bioequivalence was the subject of the original resolution, existing MMS policies recognize the long standing issues of bioequivalence in generics. For example,

 

The MMS shall support legislative and regulatory positions, which support the rights of

patients and physicians to choose the appropriate medication for the patient on a

clinical basis.

 

Physicians should not be pressured to change stabilized patients‘ drugs for

economic reasons only. Substitutions should be prescribed only for the benefit of the

patient. Insurers should be encouraged to allow this practice.3

 

However, biosimilars have not been addressed by existing MMS policy.

Based on those discussions, CQMP agrees with the COL’s recommendation from A-10 to endorse the AMA’s policy on biosimilars and to include an additional AMA policy that CQMP recommends the MMS endorse related to follow-on biologic medications. Second, CQMP recommends a directive to work with the AMA and FDA on the issue of bioequivalence.

 

Recommendations:

 1.    That the MMS endorse the following AMA policies:

 

D-125.989 Substitution of Biosimilar Medicines and Related Medical Products

Our AMA will: (1) monitor legislative and regulatory proposals to establish a

pathway to approve follow-on biological products and analyze these proposals to

ensure that physicians retain the authority to select the specific products their

patients will receive; and (2) work with the U.S. Food and Drug Administration and

other scientific and clinical organizations to ensure that any legislation that

establishes an approval pathway for follow-on biological products prohibits the

automatic substitution of biosimilar medicines without the consent of the patient’s

treating physician. (Res. 918, I-08) (HP)

 

H-125.980 Follow-on Biologic Medications.

 

AMA policy is that pharmaceutical companies should be allowed to make followon

biologic medications available to physicians and their patients in a reasonable

period of time with a reasonably predictable pathway to bring them to market, and

our AMA will advocate for enactment of federal law that would establish a pathway

for follow-on biologic medications to be allowed on the market, with two guiding

principles: 1) a reasonable time frame for US Food and Drug Administration

exclusivity and patent expiration with a straightforward regulatory process for

follow-on biologic competitors to be brought to market, and 2) the protection of

patient safety in both the original branded products and all follow-on products

that are brought to market. (Res. 220, A-09) (HP)

 

2. That the MMS and AMA would work with the FDA and any other relevant

regulatory bodies that are responsible for assessing variance in bioequivalency and bioavailability of generic products and branded products so that the MMS and AMA are able to provide policy recommendations. (D)

 

 

MASSACHUSETTS MEDICAL SOCIETY HOUSE OF DELEGATES

 

 

Code: Resolution:  104, I-09 (A)
Title:    Physician-Patient Relationship

Sponsor:  Matthew D. Gold, MD

Referred to:   Reference Committee

Whereas, Advocating for universal coverage that is patient-centered is a Massachusetts Medical Society strategic priority; and

Whereas, When the universal health care reform initiative in Massachusetts was first implemented in 2006, the Commonwealth provided health insurance coverage for legal immigrants under the Commonwealth Care Health Insurance Program, including “aliens with special status” (AWSS).  These are immigrants who have applied for residency but who have not yet been in the country long enough to be eligible for Medicaid-funded services; and 

Whereas, Due to budget cuts made by the Legislature, the Commonwealth Care system decided to terminate benefits for the AWSS category, which was appropriated $130 million in FY09.  The Legislature appropriated $40 million for FY10; and

Whereas, Governor Patrick ultimately assigned AWSS care to a for-profit plan, CeltiCare of Massachusetts, which in turn is contracting with Caritas (and Partners as tertiary care) to provide primary care for this population.  This will result in longstanding physician-patient relationships being terminated for many legal alien residents and their doctors.  Additionally, there arguably will not be enough primary care physicians in place to serve the existing AWSS population (31,000); and

Whereas, In an era where national trends in health care reform include the concept of portability of health insurance, it is ironic that the state pioneering a serious initiative to attain universal health care would do so by compromising the most basic principle of good health care undefined namely, the existing and ongoing physician-patient relationship; and

Whereas, Due to the necessity to control health care costs, a number of new initiatives from industry and government have been proposed with little input from practicing physicians; and

Whereas, In the opinion of many, the physician-patient relationship is the most important factor in assuring both continuity and quality of care; and

Whereas, New initiatives that mandate restricted panels of primary care and specialty physicians frequently interfere with established physician-patient relationships, and often include termination of longstanding relationships on purely financial grounds; therefore, be it

RESOLVED, That the Massachusetts Medical Society vigorously oppose any industry or government initiative, proclamation, and/or legislation that mandates termination of or places severe restrictions on established physician-patient relationships.  (D)

Fiscal Note:                                                     No Significant Impact

(Out of Pocket Expenses)                         

FTE:    Existing Staff

(Staff Effort to Complete Project)

 

[Outcome: The above language was discarded; a 90 minute discussion ensued supporting the contention that in any healthcare system or arrangement, that the ‘primacy of the physician-patient relationship’ be respected.]