Specialty Pharmacy/Biosimilars

Generic Drug Products

Policy 9911

11/01/1999 Introduced
02/01/2005 Revised
11/01/2009 Revised
02/01/2014 Revised

AMCP encourages pharmacists and managed health care systems to promote the use and benefits of FDA-approved and therapeutically equivalent generic drug products as safe, effective, and cost-effective alternatives to brand-name equivalents. AMCP supports legislative and regulatory changes that would promote the development and use of safe, efficacious and equivalent generic drugs and eliminate barriers that can unnecessarily delay the entry of the generic drugs into the marketplace. AMCP believes that Congress must ensure that the FDA has access to adequate resources in order to review and process applications for generic drugs and eliminate unnecessary delays of their approval.  AMCP opposes state and federal legislative and regulatory provisions that would restrict the right of pharmacists, in collaboration with prescribers and patients, to exercise their professional judgment in choosing the most appropriate generic or brand-name equivalent products for patients.

(See AMCP Where We Stand Position Statement – Generic Drugs)

(See also AMCP Where We Stand Position Statement - Biosimilar Drug Therapies)

Specialty Pharmaceuticals and Related FDA Approved Products

Policy 0112

03/01/200 Introduced
02/01/2006 Revised
12/01/2010 Revised
02/21/2021 Revised

AMCP supports the leadership role of pharmacists within specialty pharmacy, including ensuring the proper use, storage, control, safe handling, preparation, distribution, administration, and care management processes for these medications. Specialty pharmaceuticals are generally high-cost medications, usually prescribed for people with complex or chronic medical conditions, or they may be medications that typically exhibit one or both of the following characteristics:

• drugs that have unique monitoring, storage, or shipment requirements; and 

• drugs that require additional patient education and support from a health care team which includes a pharmacist with specialty medication experience.

Restricted Distribution of Pharmaceuticals

Policy 0119

11/01/2001 Introduced
02/01/2006 Revised
12/01/2010 Revised
04/07/2015 Revised

AMCP generally opposes any restrictions on the distribution of pharmaceutical products either by the pharmaceutical industry or as a condition for FDA-approval. AMCP acknowledges that circumstances may occur with the use of specific medications that require special distribution, monitoring and management processes.  As long as,

  
1. The requirements do not interfere with the continuity of care for the patient;
2. The requirements preserve the pharmacist-patient relationship;
3. The requirements are based on scientific evidence fully disclosed and evaluated by physicians, pharmacists, and others;

4. There is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care;
5. The cost of the product and any associated product or services are identified for purposes of reimbursement, mechanisms are provided to compensate providers for special services, and duplicative costs are avoided;

6. All requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients;

7. The requirements do not interfere with the professional practice of pharmacists, physicians, or other appropriately qualified healthcare professionals.
 
(The enumerated principles are drawn from ASHP Principles for Restricted Distribution Systems. June 2007)

Biosimilar Drug Therapies

Policy 0802

06/01/2008 Introduced
04/01/2012 Revised
10/01/2012 Reapproved

AMCP supports an abbreviated licensure pathway for the approval of biosimilar biologic drug therapies. In order to strike an appropriate balance between bringing safe and effective drugs to market and maximizing patient access to affordable drugs, the FDA should determine on a case-by-case basis the need for additional clinical studies prior to approval, as well as any post-marketing studies. Manufacturers of approved biosimilars should be allowed to use the same government-approved/international non-proprietary name as the reference product. The FDA should also provide clear rules for the designation of a biosimilar product as interchangeable with a reference product, similar to the current “AB” ratings used for small-molecule chemical drugs. A designation of interchangeability should not be a requirement as a condition for approval of a biosimilar product.

(See AMCP Where We Stand Position Statement – Biosimilar Drug Therapies)

Preferred Pharmacy Networks

Policy 1401

07/29/14 Introduced

The Academy of Managed Care Pharmacy (AMCP) supports the ability of health plans to offer preferred pharmacy networks for their enrollees as a way of providing additional options and cost savings without any diminishment of quality or patient access.  Preferred pharmacy networks represent an important tool and innovation in managed care pharmacy benefits.  The Academy supports the continued use of these programs as a beneficial way to maintain quality of care, access and cost effectiveness to the pharmacy benefit.