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P&t formulary decisions - july 2013
From: Sheireen Huang, Pharm.D.
Pharmacy Co-Chair, Physician Co-Chair, Regional P&T Committee
CC: Pharmacy Date: July 5, 2013 Re: July P&T Committee Formulary Decisions
The chart below outlines KPMAS commercial formulary decisions from the July 2013 KPMAS Regional Pharmacy & Therapeutics Committee meeting. Detailed evidence-based drug monographs used when evaluating these products are available by request. In addition, please see the attached for summary of tips on how to find formulary information online and the formulary review process. Please feel free to contact Sheireen Huang, PharmD and/or Carol Forster, MD via email at [email protected] and/or [email protected] if there are any questions.
Commercial and Medicare Part D (MPD) Formulary Decisions DRUG AND STRENGTH RESTRICTION/COMMENT
As a multi-source generic, sildenafil 20 mg provides a
cost-effective phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (off-label) and pulmonary arterial hypertension (PAH) in adults.
Reviewed and voted to MAINTAIN generic Revatio on
the commercial formulary with prescribing for the treatment of PAH restricted to Cardiology and Pulmonology but unrestricted for all other uses.
When prescribed for erectile dysfunction, the following
quantity limits will apply per 30 day-supply based on the dose of Viagra:
o Viagra 25 mg = sildenafil 20 mg, 8 tablets o Viagra 50 mg = sildenafil 20 mg, 24 tablets o Viagra 100 mg = sildenafil 20 mg, 40 tablets
Maintain generic Revatio on Tier 2 of the MPD
Adcirca has similar efficacy and safety compared to
sildenafil 20 mg (generic Revatio), which is the KPMAS-preferred option for treating patients with pulmonary arterial hypertension.
Reviewed and voted to REMOVE from the commercial
Adcirca will be available via the formulary exception
Maintained on Tier 5 of the MPD formulary.
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
Commercial and Medicare Part D (MPD) Formulary Decisions (cont’d) DRUG AND STRENGTH RESTRICTION/COMMENT
Preservative-free (sulfite-free) epinephrine 1 mg/mL
injection for intracameral injection is on manufacturer
Reviewed and voted to ADD compound lidocaine 1%
and phenylephrine 1.5 %/1 mL injection as an alternative; effective 8/5/2013.
Compounding will be outsourced to Leiter’s Pharmacy
Product is exempt from MPD formulary.
Given use in clinic, ADD Gelfoam (absorbable gelatin
sponge) size 12 (2 x 7 mm), and size 100 (8 x 12.5 cm) to the commercial formulary; effective 8/5/2013.
Product is exempt from MPD formulary.
Class Review: Platelet-aggregation No changes recommended.
Class Review: Thrombolytic Agents No changes recommended.
Class Review: Antiarrythmic Agents No changes recommended.
Class Ia, Class Ib, Class Ic, Class III, Class IV Class Review: Cardiotonics
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
Commercial and Medicare Part D (MPD) Formulary Decisions (cont’d) DRUG AND STRENGTH RESTRICTION/COMMENT
Reductase Inhibitors Class Review: Miscellaneous
Class Review: Hypotensive Agents No changes recommended.
Adrenergic Inhibitors Class Review: Vasodilating Agents No changes recommended.
Class Review: Nitrates and Nitrites No changes recommended.
See decisions above for Adcirca and generic Revatio.
Type-5 Inhibitors Class Review: Miscellaneous
Vasodilating Agents Class Review: Sclerosing Agents
Blocking Agents Class Review: β-Adrenergic
Blocking Agents Class Review: Calcium-Channel
Blocking Agent Class Review: Dihydropyridines
Calcium-Channel Blockers Class Review: Renin-Angiotensin-
Aldosterone System Inhibitors Class Review: Angiotensin-
Converting Enzyme Inhibitors Class Review: Angiotensin II
Receptor Antagonists Class Review: Aldosterone
Receptor Antagonists Class Review: Renin Inhibitors
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
Commercial and Medicare Part D (MPD) Formulary Decisions (cont’d) DRUG AND STRENGTH RESTRICTION/COMMENT
Inhibitors Class Review: Amylinomimetics
REMOVE Lantus OptiClik SC 100 unit/mL
solution from the commercial formulary; effective 8/5/13. Product has been discontinued.
REMOVE Lantus Solostar SC 100 unit/mL
solution from the commercial formulary, effective 8/5/13.
REMOVE Humalog KwikPen SC 100 unit/mL
solution from the commercial formulary; effective 8/5/13.
REMOVE Humalog Pen SC 100 unit/mL
solution from the commercial formulary, effective 8/5/13.
Insulin pens are non-formulary items under the
commercial formulary; insulin vials are available
Commercial and Medicare Part D (MPD) Formulary Decisions (cont’d) DRUG AND STRENGTH RESTRICTION/COMMENT
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
Class Review: Somatropin Agonists Omnitrope 5 mg/ 1.5 mL and 10 mg/1.5 mL SC
solution are the preferred formulary somatropin agonists.
REMOVE the following products from the
Norditropin FlexPro SC 5 mg/1.5 mL solution
Norditropin FlexPro SC 10 mg/1.5 mL solution
Norditropin NordiFlex Pen SC 5 mg/1.5 mL solution
Norditropin NordiFlex Pen SC 10 mg/1.5 mL solution
Norditropin SC 5 mg/1.5 mL solution (discontinued)
Luteum Hormones Class Review: Thyroid Agents
Therapeutic Agents Class Review: Disease-modifying
Inter-regional MPD Pharmacy and Therapeutics (iM-PacT) Committee Decisions (Recently launched and approved products) DRUG AND STRENGTH RESTRICTION/COMMENT
Placed on Specialty Tier 5 of MPD formulary; effective
Placed on Specialty Tier 5 of MPD formulary; effective
Treatment of chronic idiopathic constipation and
irritable bowel syndrome with constipation (IBS-C) in adults.
Specialist review in progress, remains on Non-
For the Reduction of Triglyceride Levels in Adult
Patients With Severe Hypertriglyceridemia
Specialist review in progress, remains on Non-
Apixaban (Eliquis) tab 2.5 mg and 5 To prevent stroke and systemic embolism in patients
Specialist review in progress, remains on Non-
Anakinra (Kineret) injection 100 mg For the treatment of children and adults with neonatal-
onset multisystem inflammatory disease (NOMID)
New indication for Specialty Tier 5, review not
Effective dates reflect implementation into the systems.
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
KAISER PERMANENTE Mid-Atlantic States Region Pharmacy & Therapeutics Committee
On the Kaiser Permanente Intranet 1. Where can I find the drug formulary online?
Click on “Formulary” link on KPHealthConnect home page (bottom right), or MAPMG Providers via intranet: Go to http://pithelp.co.kp.org/MAS/phcy_therpeutics.html Network Providers: Go
http://providers.kp.org/mas/formulary.html
2. How can I find out if something is on the drug formulary and view the drug monograph for a drug on the formulary? MAPMG Providers To view the criteria for use, contraindications, adverse reactions, drug interactions, and
dosing information, click on the Lexi-comp® Interactive Version under Full MAS Drug Formulary. When you enter the site, a search screen appears in the upper left hand corner of your screen. Type in the first few letters or the entire drug name and select SEARCH. All drugs containing that information are listed in the SEARCH RESULTS box. If a drug is not on formulary or it is spelled incorrectly, "No occurrences found" will appear in the SEARCH RESULTS box.
Formulary status of a particular drug can be found in HealthConnect™ in the “Pharmacy”
column in the drug listing. “Yes” in this column means that particular product is formulary. Remember, there are sometimes many duplicative products for a single drug entity. In that event, scroll down the list to look for the product that is formulary.
http://providers.kp.org/mas/formulary.html
Click on comprehensive listing of formulary drugs
Press (ctrl+F) and search for the particular drug of interest on the “Find” field appearing on
If the drug is spelled incorrectly or is not on the formulary the following message will appear
3. How can I receive a copy of the formulary?
MAPMG Providers
http://pithelp.co.kp.org/MAS/formulary.html
You may print a copy of the formulary document Network Providers Go
http://providers.kp.org/mas/formulary.html
Click on comprehensive listing of formulary drugs
You may print a copy of the formulary document
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
You may also contact our Provider Relations Department at 1-877-806-7470 for a paper copy of our formularies.
4. How can I request an addition or deletion from the formulary?
New drug entities remain Non-formulary until reviewed by the Regional P&T Committee.
We will review any drug upon written request with supporting evidence to make an evidence-based decision. The Drug Formulary Addition and Deletion Request Form can be obtained via the internet for both MAPMG and Network Providers:
http://pithelp.co.kp.org/MAS/documents/phcy_therpeutics/formulary_addition_deletion_request.pdf
http://providers.kp.org/mas/formulary.html
Under section “Request to review medications for addition/deletion to the formulary”,
1. Faxed at 301-816-6372, attention: P&T Committee co-chairs 2. Mailed to:
Kaiser Permanente Regional Office, Pharmacy 3-West Attention: P&T Committee Co-Chairs, Drug Review 2101 East Jefferson Street Rockville, MD 20852
3. Emailed by contacting any of the P&T Committee Co Chairs:
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
FORMULARY REVIEW PROCESS Applying evidence-based medicine, the Regional P&T Committee and its Consultants determine whether a medicine should be added to the drug formulary. The key points of this evidence-based review are highlighted; a full description of the formulary review process is available on www.mapmgonline.com, within the Pharmacy Group. EFFICACY Lack of compelling evidence High ETY probability of EFFICACY medication error “Me-Too” Drugs Potential Need for Therapeutic Monitoring FORMULARY Limited Indication Counters KP’s Mission Strong Potential for Misuse THERAPEUTIC STEWARDSHIP Non-formulary Considerations
Drug accepted on basis of sound clinical evidence that supports it’s: 1st line therapy; standard of care
Bioequivalent to existing drugs, most cost-effective
Status encourages use over NF agents
Drug not accepted due to concerns in 1 or more of the following:
Duplicate Bioequivalent Agents, not cost-effective
IN ADDITION TO FORMULARY OR NON-FORMULARY STATUS, DRUGS MAY BE RESTRICTED TO PRESCRIBING CRITERIA OR TO PRESCRIBER SPECIALTY DUE TO ISSUES REGARDING:
Limited indications/uses of drug endorsed
*Stewardship: We ensure our stewardship using and managing our resources appropriately - KP-MAS
Regional Pharmacy & Therapeutics Committee July 2013 Formulary Decisions
Submitted by: Paulette E. Crawford, PharmD, CGP
AK and the Histamine Problem Wolfgang F. Gerz, M.D., DIBAK Abstract One of the most important screening tests in Applied Kinesiology (AK) since the mid-eighties has been the testing with histamine 12X or the actual amino acid histidine to identify the “Histamine Allergy” (Schmitt;1, 2, 3 Lebowitz4). This screening has been very successfully used in the nineties in the German speakin
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