{"id":17550,"date":"2019-11-14T09:00:44","date_gmt":"2019-11-14T14:00:44","guid":{"rendered":"https:\/\/www.benefitscanada.com\/news\/proposed-changes-to-ontario-drug-rules-target-generics-pricing-biosimilar-listing-process-138894"},"modified":"2019-11-14T09:00:44","modified_gmt":"2019-11-14T14:00:44","slug":"proposed-changes-to-ontario-drug-rules-target-generics-pricing-biosimilar-listing-process","status":"publish","type":"post","link":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/2019\/11\/14\/proposed-changes-to-ontario-drug-rules-target-generics-pricing-biosimilar-listing-process\/","title":{"rendered":"Proposed changes to Ontario drug rules target generics pricing, biosimilar listing process"},"content":{"rendered":"<div class=\"alignleft clearfix\">\n<div class=\"wp-caption feature-image alignleft\"><img decoding=\"async\" loading=\"lazy\" width=\"316\" height=\"190\" src=\"https:\/\/www.benefitscanada.com\/wp-content\/uploads\/2018\/11\/76120467_l-OntarioLegislature-123RF.jpg\" class=\"attachment-feature size-feature wp-post-image\" alt=\"123RF.com\/Diego Grandi\" title=\"Proposed changes to Ontario drug rules target generics pricing, biosimilar listing process\"> <\/div>\n<\/div>\n<p class=\"byline\"><span>Staff<\/span>&nbsp;|&nbsp;November 14, 2019<\/p>\n<p class=\"p1\"><span class=\"s1\">Ontario has proposed&nbsp;amendments to provincial drug regulations that aim to change the pricing model for generic drugs and simplify the process<\/span><span class=\"s1\">&nbsp;for the province\u2019s drug formulary to list biosimilars.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Ontario\u2019s&nbsp;Ministry of Health and Long-Term Care&nbsp;said the changes are aimed at&nbsp;reducing the \u201cadministrative burden\u201d for drug manufacturers and pharmacies.<\/span><\/p>\n<p class=\"p1\">With regards to&nbsp;generic drug pricing rules, the current pricing model,&nbsp;created by the pan-Canadian Pharmaceutical Alliance, is&nbsp;tiered based&nbsp;on the number of competitors in the market.&nbsp;Generic prices&nbsp;begin at 75 or 85 per cent of the brand price&nbsp;for the first entrant and decrease as more generics are introduced. The proposals would permit generic manufacturers to automatically adjust their prices as their price tier changes,&nbsp;rather than&nbsp;requiring them to apply for an adjustment, which the ministry expects will lower generic prices nationally.<\/p>\n<p class=\"p1\"><strong>Read:&nbsp;<a href=\"https:\/\/www.benefitscanada.com\/news\/generic-drug-industry-governments-reach-deal-to-cut-prices-by-up-to-40-109903\">Generic drug deal hailed for price cuts of up to 40% for public, private plans<\/a><\/strong><\/p>\n<p class=\"p1\"><span class=\"s1\">The&nbsp;proposals would also speed up the biosimilar listing process by&nbsp;no longer&nbsp;requiring manufacturers to provide scientific evidence of clinical similarity between the biosimilar and its originator product,&nbsp;since Health Canada makes that assessment before approving the drug.<\/span><\/p>\n<p class=\"p1\">\u201cIt is not necessary for Ontario to re-review the same scientific evidence,\u201d the ministry said in a document explaining the proposed changes. \u201c[The change] would reduce submission requirements so that biosimilars would be funded more quickly to create fiscal space for new drug products.\u201d<\/p>\n<p class=\"p1\">Ontario\u2019s proposal comes on the heels of a similar adjustment by the Canadian Agency for Drugs and Technologies in Health in May 2019 to&nbsp;stop&nbsp;its reviews of&nbsp;biosimilars on the grounds that it could delay patient access to new biosimilar treatments. It also precedes&nbsp;British Columbia\u2019s Nov. 25 deadline&nbsp;to transfer all patients using biologics for&nbsp;select illnesses&nbsp;to transition to biosimilars as part of its expanded biosimilars initiative.<\/p>\n<p class=\"p1\">The proposed changes&nbsp;would also permit generic manufacturers to offer larger&nbsp;prescribed discounts to wholesalers and pharmacies. Ontario prohibits drug manufacturers from offering \u201crebates\u201d to either, but makes exceptions for discounts of&nbsp;10 per cent of the value of the generic drug\u2019s price in the Ontario formulary,&nbsp;known as \u201cordinary commercial terms.\u201d The changes would&nbsp;increase the discount to a cap of 25 per cent, bringing Ontario\u2019s policies&nbsp;closer to other Canadian jurisdictions. Ontario and Quebec are the only provinces to prevent rebates or professional allowances.<\/p>\n<p class=\"p1\"><strong>Read:&nbsp;<a href=\"https:\/\/www.benefitscanada.com\/news\/b-c-government-says-expanding-biosimilars-will-save-nearly-100-million-over-three-years-130763\">B.C. government says expanding biosimilars will save nearly $100 million over three years<\/a><\/strong><\/p>\n<p> <a href=\"https:\/\/www.benefitscanada.com\/news\/proposed-changes-to-ontario-drug-rules-target-generics-pricing-biosimilar-listing-process-138894\">Read the full article at BenefitsCanada.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Staff&nbsp;|&nbsp;November 14, 2019 Ontario has proposed&nbsp;amendments to provincial drug regulations that aim to change the pricing model for generic drugs and simplify the process&nbsp;for the province\u2019s drug formulary to list biosimilars. Ontario\u2019s&nbsp;Ministry of Health&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[],"tags":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/17550"}],"collection":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/comments?post=17550"}],"version-history":[{"count":0,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/17550\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/media?parent=17550"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/categories?post=17550"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/tags?post=17550"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}