20-824 Medication Trend Updates and Preferred Drug List Changes - 4th Quarter 2020
Date: 10/22/20
This information applies to Physicians & Participating Physician Groups (PPGs).
This information applies to Medi-Cal in Fresno, Kings and Madera counties.
Summary
Review changes that improve patient safety and encourage medication adherence
Stay up-to-date with information about:
- U.S. Food and Drug Administration (FDA) labeling update for opioid pain medicines and opioid use disorder (UOD) medicines by recommending increased access to naloxone
- Naloxone and other FDA-approved drugs under Assembly Bill (AB) 2760
- Health plan uses biosimilars
- Alternative sites of infusion care for Medi-Cal members
- Changes to the CalViva Health Medi-Cal Preferred Drug List (formulary) for the fourth quarter of 2020
FDA labeling update for opioid pain medicines and opioid use disorder medicines by recommending increased access to naloxone
In July 2020, the FDA announced labeling for opioid analgesics and medicine to treat OUD must be updated to recommend that health care professionals discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment and should consider co-prescribing naloxone to patients at increased risk of opioid overdose in the following conditions:
- All patients prescribed medications for OUD (e.g., buprenorphine, methadone and naltrexone).
- For all patients prescribed opioid pain medicines who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose.
- For patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
The FDA is requiring that these recommendations are added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone.
Naloxone hydrochloride and other FDA-approved drugs
To address the opioid overdose epidemic, Assembly Bill (AB) 2760 requires prescribers to offer naloxone or another drug approved by the FDA for high-risk patients. Prescribing naloxone is also an opportunity to initiate a discussion with patients on the risk of overdose.
AB 2760 states that prescribers must:
- Offer a prescription for naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of opioid depression to a patient when one or more of the following conditions are present:
- The prescription dosage for the patient is 90 or more morphine milligram equivalents of an opioid medication per day.
- An opioid medication is prescribed concurrently with a prescription for a benzodiazepine.
- The patient presents with an increased risk for overdose, including a patient with a history of overdose, a patient with a history of substance use disorder, or a patient at risk for returning to a high dose of opioid medication to which the patient is no longer tolerant.
- Provide education to patients receiving a prescription for overdose prevention, and the use of naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of opioid depression.
- Provide education about overdose prevention and the use of naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of opioid depression to one or more persons designated by the patient, or, for a patient who is a minor, to the minor’s parent or guardian.
Health plan uses biosimilars
The FDA regulates biosimilar manufacturing to ensure they scientifically demonstrate safety and effectiveness while showing no clinically meaningful differences to existing biologic medicines. Biosimilars tend to cost less which can help lower the overall cost of care for members while still providing quality care.
Effective September 1, 2020, the health plan will prefer the following biosimilars for Medi-Cal members. For all new starts, the patient must try and fail (or have contraindications to) the preferred biosimilar before the brand name product will be approved. Specific prior authorization guidelines can be found on the provider portal.
Reference Product (Non-Preferred) | Preferred Biosimilar(s) |
|---|---|
Epogen®, Procrit® (epoetin alfa) | Retacrit® (epoetin alfa-epbx) |
Neupogen® (filgrastim) | Zarxio® (filgrastim-sndz) |
Neulasta® (peg-filgrastim)* *requires Zarxio® step requirement |
|
Remicade® |
|
Rituxan® | Ruxience® (rituximab-pvvr) |
Avastin® (for non-ophthalmic diagnoses) |
|
Herceptin® |
|
Alternative sites of infusion care for Medi-Cal members
The plan has options available for members who are being treated with any of the infusion products listed in the table below. Members have the option to transition infusions from the hospital to the home, an ambulatory infusion suite (AIS) or a nearby physician’s office. Alternate site of infusion care is part of a member's standard benefits.
Health Net, on behalf of CalViva Health, has partnered with Coram® CVS Specialty™ Infusion Services as the designated preferred provider for these infusions. Coram provides more than 35 years of experience; certified clinicians who specialize in drug therapy and patient monitoring; offers the convenience of in-home infusions with clinical support available 24/7; and, infusions may be offered at a lower cost to patients.
For patient referrals or additional information, contact Peter Tran, Pharm.D, at (714) 934-3362, Monday through Friday, from 9 a.m. to 4 p.m., and reference the Site of Care Optimization of Therapeutic Infusion (SCOTI) Program.
| Infusion Care Type | Products |
|---|---|
Alpha-1 Antitrypsin Deficiency | Aralast™ NP, Glassia®, Zemaira® |
Amyloidosis | Onpattro® |
Asthma | Cinqair®, Fasenra®, Nucala®, Xolair® |
Autoimmune Disorders | Actemra®, AvsolaTM, Entyvio®, Inflectra®, Orencia®, Remicade®, Renflexis®, Simponi Aria® |
Hereditary Angioedema | Cinryze® |
Immune Deficiencies and Related disorders
| Asceniv®, Bivigam®, Carimune®, Cuvitru®, Flebogamma®, Gammagard® Liquid, Gammagard® S/D, Gammaked™, Gammaplex®, Gamunex®-C, Hizentra®, Hyqvia®, Octagam®, Panzyga®, Privigen®, Xembify® |
Lysosomal Storage disorders | Aldurazyme®, Cerezyme®, Elaprase®, Elelyso®, Fabrazyme®, Kanuma®, Lumizyme®, Naglazyme®, Vimizim®, Vpriv® |
Movement disorders | Radicava® |
Multiple Sclerosis | Lemtrada®, Ocrevus®, Tysabri® |
Ocular Disorders | Tepezza® |
Paroxysmal Nocturnal Hemoglobinuria | Soliris®, Ultomiris® |
Rare Disorders | Crysvita® |
Sickle Cell Disease | Adakveo® |
Systemic Lupus Erythematosus | Benlysta® |
Preferred Drug List changes
A list of recent changes to the CalViva Health Medi-Cal Preferred Drug List is available in the complete provider update
20-824, Learn About Medication Trend Updates and Preferred Drug List Changes – 4th Quarter 2020. The list contains brand-name prescription medications, status, alternatives, and comments. A complete CalViva Health Medi-Cal Preferred Drug List is available on the provider website under Pharmacy Information.
To obtain a comprehensive description of the above topics, the complete update is included below. You may request a print copy by contacting the Provider Communications Department by email.
Additional information
If you need additional information regarding the CalViva Health Medi-Cal Preferred Drug List, contact the Pharmacy Department by telephone at 1-800-867-6564, press option #2, or by fax at 1-800-977-8226. For all other questions, contact CalViva Health at 1-888-893-1569.
†Any transfer of information or data between providers and/or facilities about a member’s OUD or SUD must first be authorized by the member before transferring the information or data between providers and/or facilities. This can be done by having the member sign an Authorization for Disclosure (AFD) form and designating the provider or entity that will be reviewing the member’s data.
Complete
Review changes that improve patient safety and encourage medication adherence
Stay up-to-date with information about:
- U.S. Food and Drug Administration (FDA) labeling update for opioid pain medicines and opioid use disorder (UOD) medicines by recommending increased access to naloxone
- Naloxone and other FDA-approved drugs under Assembly Bill (AB) 2760
- Health plan uses biosimilars
- Alternative sites of infusion care for Medi-Cal members
- Changes to the CalViva Health Medi-Cal Preferred Drug List (formulary) for the fourth quarter of 2020
FDA labeling update for opioid pain medicines and opioid use disorder medicines by recommending increased access to naloxone
In July 2020, the FDA announced labeling for opioid analgesics and medicine to treat OUD must be updated to recommend that naloxone availability be discussed as a routine part of prescribing these medicines. Naloxone is an opioid antagonist. If administered promptly after overdose by individuals with or without medical training, it may reverse the effects, often within minutes.
The FDA recommends that health care professionals discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment and should consider co-prescribing naloxone to patients at increased risk of opioid overdose in the following conditions:
- All patients prescribed medications for OUD (e.g., buprenorphine, methadone and naltrexone.
- For all patients prescribed opioid pain medicines who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose.
- For patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
The FDA is requiring that these recommendations are added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone. Patients should speak with their health care professional about how to obtain naloxone according to their state’s requirements or guidelines.
Naloxone hydrochloride and other FDA-approved drugs
To address the opioid overdose epidemic, Assembly Bill (AB) 2760 requires prescribers to offer naloxone or another drug approved by the FDA for high-risk patients. Prescribing naloxone is also an opportunity to initiate a discussion with patients on the risk of overdose.
AB 2760 states that prescribers must:
- Offer a prescription for naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of opioid depression to a patient when one or more of the following conditions are present:
- The prescription dosage for the patient is 90 or more morphine milligram equivalents of an opioid medication per day.
- An opioid medication is prescribed concurrently with a prescription for a benzodiazepine.
- The patient presents with an increased risk for overdose, including a patient with a history of overdose, a patient with a history of substance use disorder, or a patient at risk for returning to a high dose of opioid medication to which the patient is no longer tolerant.
- Provide education to patients receiving a prescription for overdose prevention, and the use of naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of opioid depression.
- Provide education about overdose prevention and the use of naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of opioid depression to one or more persons designated by the patient, or, for a patient who is a minor, to the minor’s parent or guardian.
Health plan uses biosimilars
The FDA approved safe and effective medicines that are highly similar to existing biologic medicines. The FDA regulates biosimilar manufacturing to ensure they scientifically demonstrate safety and effectiveness while showing no clinically meaningful differences. Biosimilars tend to cost less than their brand name counterparts which can help lower the overall cost of care for members while still providing quality care.
Effective September 1, 2020, the health plan began using the following biosimilars over their brand counterparts for Medi-Cal members. For all new starts, the patient must try and fail (or have contraindications to) the preferred biosimilar before the referenced name product will be approved.
Specific prior authorization guidelines can be found on the provider portal.
Reference Product (Non-Preferred) | Preferred Biosimilar(s) |
|---|---|
Epogen®, Procrit® (epoetin alfa) | Retacrit® (epoetin alfa-epbx) |
Neupogen® (filgrastim) | Zarxio® (filgrastim-sndz) |
Neulasta® (peg-filgrastim)* *requires Zarxio® step requirement |
|
Remicade® |
|
Rituxan® | Ruxience® (rituximab-pvvr) |
Avastin® (for non-ophthalmic diagnoses) |
|
Herceptin® |
|
Alternative sites of infusion care for Medi-Cal members
The plan has options available for members who are being treated with any of the infusion products listed in the table below. Members have the option to transition infusions from the hospital to the home, an ambulatory infusion suite (AIS) or a nearby physician’s office. Alternate site of infusion care is part of a member's standard benefits.
Health Net, on behalf of CalViva Health, has partnered with Coram® CVS Specialty™ Infusion Services as the designated preferred provider for these infusions. Coram provides:
- Experience. More than 35 years of experience in specialized infusion care and demonstrated expertise in the delivery and administration of complex specialty infused medications. The only national home infusion provider accredited by The Joint Commission.
- Safety. Clinicians are certified and specialize in delivery of chronic and complex drug therapy and careful patient monitoring. Experienced nurses stay for the entire infusion duration ensuring patients receive high-level care.
- Convenience. In-home and AIS-based infusions are scheduled directly with patients, enabling flexibility, independence and enhanced quality of life. Clinical support is available to patients 24 hours a day, seven days a week.
- Lower costs. Infusions may be provided at a lower cost to patients promoting compliance to therapy and ultimately improve outcomes and reduce health costs.
For patient referrals or additional information, contact Peter Tran, Pharm.D, at (714) 934-3362, Monday through Friday, from 9 a.m. to 4 p.m., and reference the Site of Care Optimization of Therapeutic Infusion (SCOTI) Program.
| Infusion Care Type | Products |
|---|---|
Alpha-1 Antitrypsin Deficiency | Aralast™ NP, Glassia®, Zemaira® |
Amyloidosis | Onpattro® |
Asthma | Cinqair®, Fasenra®, Nucala®, Xolair® |
Autoimmune Disorders | Actemra®, AvsolaTM, Entyvio®, Inflectra®, Orencia®, Remicade®, Renflexis®, Simponi Aria® |
Hereditary Angioedema | Cinryze® |
Immune Deficiencies and Related disorders
| Asceniv®, Bivigam®, Carimune®, Cuvitru®, Flebogamma®, Gammagard® Liquid, Gammagard® S/D, Gammaked™, Gammaplex®, Gamunex®-C, Hizentra®, Hyqvia®, Octagam®, Panzyga®, Privigen®, Xembify® |
Lysosomal Storage disorders | Aldurazyme®, Cerezyme®, Elaprase®, Elelyso®, Fabrazyme®, Kanuma®, Lumizyme®, Naglazyme®, Vimizim®, Vpriv® |
Movement disorders | Radicava® |
Multiple Sclerosis | Lemtrada®, Ocrevus®, Tysabri® |
Ocular Disorders | Tepezza® |
Paroxysmal Nocturnal Hemoglobinuria | Soliris®, Ultomiris® |
Rare Disorders | Crysvita® |
Sickle Cell Disease | Adakveo® |
Systemic Lupus Erythematosus | Benlysta® |
Preferred Drug List changes
The Pharmacy and Therapeutics (P&T) Committee, which includes practicing physicians, pharmacists and other health care professionals, reviews medications on the CalViva Health Medi-Cal Preferred Drug List each quarter to determine medications to stay on or be moved to a different status. A list of some recent changes is provided in the table below. A complete CalViva Health Medi-Cal Preferred Drug List is available on the provider website under Pharmacy Information.
Medication | Status | Formulary alternative(s) | Comments |
|---|---|---|---|
Inrebic® (fedratinib) capsule | NF | Jakafi** | Treatment of adult patients with intermediate-2 or high risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) |
Rozlytrek® (entrectinib) capsule | NF | ROS1 positive: Xalkori® *,**
| Treatment of the following:
|
*Prior authorization (PA) is required to verify member eligibility and that the member satisfies clinical protocols to ensure appropriate use of the medication.
**CCS = California Children’s Services: refer to www.dhcs.gov for the local telephone number to determine member’s coverage eligibility.
NF indicates nonformulary. These medications require member-specific medical reasons why formulary medications cannot be considered. Requests are reviewed via the plan’s prior authorization process.
Additional information
Providers are encouraged to access the provider portal online for real-time information, including eligibility verification, claims status, prior authorization status, plan summaries, and more.
If you need additional information regarding the CalViva Health Medi-Cal Preferred Drug List, contact the Pharmacy Department by telephone at 1-800-867-6564, press option #2, or by fax at 1-800-977-8226. For all other questions, contact CalViva Health at 1-888-893-1569.
†Any transfer of information or data between providers and/or facilities about a member's OUD or SUD must first be authorized by the member before transferring the information or data between providers and/or facilities. This can be done by having the member sign an Authorization for Disclosure (AFD) form and designating the provider or entity that will be reviewing the member's data.